FDA Device · 2014
FDA Device recalls in 2014
RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.
- Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1) CARDIOVASCU.LAR INCISE DRAPE L/Free (2) 3/4 ABS. R…
FDA Device · Class I · 2014-09-10 · Customed - PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONGES 4" X 4" 12PLY LIF (2) LEGGINS WITH 7" CUFF 30" x…
FDA Device · Class I · 2014-09-10 · Customed - Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodial…
FDA Device · Class II · 2014-09-10 · Medical Components - OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/NEEDLE 21 G…
FDA Device · Class I · 2014-09-10 · Customed - PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top
FDA Device · Class II · 2014-09-10 · Zimmer - PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 80oz WIT…
FDA Device · Class I · 2014-09-10 · Customed - ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ABDOMINAL P…
FDA Device · Class I · 2014-09-10 · Customed - CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1) DRAPE SHEET 41" X 58" SMS L/Free (1) CAP NURSE 21" GREEN BOUFFAN…
FDA Device · Class I · 2014-09-10 · Customed - Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL C…
FDA Device · Class I · 2014-09-10 · Customed - BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915
FDA Device · Class I · 2014-09-10 · Customed - EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL (1) SHEET ENT SPLIT 110"…
FDA Device · Class I · 2014-09-10 · Customed - FOCAL Sim Workstation, Radiation Treatment Planning System
FDA Device · Class II · 2014-09-10 · Elekta - LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X 20" ( 1) FEEDING TUBE…
FDA Device · Class I · 2014-09-10 · Customed - ORTHOPEDIC PACK BASIC CODE 900-2830
FDA Device · Class I · 2014-09-10 · Customed - PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSORBENT 15" X 20" UF (2) LEGGINGS W/7" CUFF 30" X 42" (1) TABLE COVER…
FDA Device · Class I · 2014-09-10 · Customed - C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANK…
FDA Device · Class I · 2014-09-10 · Customed - UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING (1) TU…
FDA Device · Class I · 2014-09-10 · Customed - Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' UF (1)…
FDA Device · Class I · 2014-09-10 · Customed - OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND COVER R…
FDA Device · Class I · 2014-09-10 · Customed - FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY…
FDA Device · Class I · 2014-09-10 · Customed - PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE…
FDA Device · Class I · 2014-09-10 · Customed - MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (1) TABLE COVER REINFORCED 50" X 9…
FDA Device · Class I · 2014-09-10 · Customed - AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42" X…
FDA Device · Class I · 2014-09-10 · Customed - DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I) DRESSING TEGADERM 3 Y2 X 4 Y2 ( I) MASK PROCEDURAL YELLOW 80MM…
FDA Device · Class I · 2014-09-10 · Customed - Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover
FDA Device · Class I · 2014-09-10 · Customed - CYSTOSCOPY PACK Ill (1) (2) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W/7" CUFF 3…
FDA Device · Class I · 2014-09-10 · Customed - PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top
FDA Device · Class II · 2014-09-10 · Zimmer - TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDL…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53" X 77" LIF (1) TUBE SUCTION CONNECT. v.i" X 12' LIF (1) SCA…
FDA Device · Class I · 2014-09-10 · Customed - PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERV. REINF. AAMI L…
FDA Device · Class I · 2014-09-10 · Customed - EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722
FDA Device · Class II · 2014-09-10 · Mentor Texas - LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF (2) LEGGINGS W/7'' CUFF 30" X 42" LIF (1) DRAPE UTILITY WITAPE…
FDA Device · Class I · 2014-09-10 · Customed - CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4" x…
FDA Device · Class I · 2014-09-10 · Customed - UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAUMGARTNE…
FDA Device · Class I · 2014-09-10 · Customed - REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF ( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF ( I) SYRIN…
FDA Device · Class I · 2014-09-10 · Customed - BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE (2) TOWELS ABSORBENT 15" X 20" (1) SUTU…
FDA Device · Class I · 2014-09-10 · Customed - ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 ) ELASTIC BANDAGE 6" X 5yds LIF (1) NEEDLE & BLADE COUNTER…
FDA Device · Class I · 2014-09-10 · Customed - O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (2) LEGGINS W/7'' CUFF 30" X 42" (1) GOWN…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFORCED LIF ( I…
FDA Device · Class I · 2014-09-10 · Customed - VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REIN…
FDA Device · Class I · 2014-09-10 · Customed - EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEED…
FDA Device · Class I · 2014-09-10 · Customed - Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) COVER…
FDA Device · Class I · 2014-09-10 · Customed - GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16oz LIF (1) TIP CAUTERY POLISHER LIF (3) TOWELS ABSORBENT 15" X 2…
FDA Device · Class I · 2014-09-10 · Customed - BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53" X 77" (1) DRAPE…
FDA Device · Class I · 2014-09-10 · Customed - EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC…
FDA Device · Class I · 2014-09-10 · Customed - PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS ABSORBENT 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X…
FDA Device · Class I · 2014-09-10 · Customed - Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER REINFO…
FDA Device · Class I · 2014-09-10 · Customed - Universal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTTOM ABSORBENT REINF…
FDA Device · Class I · 2014-09-10 · Customed - Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band…
FDA Device · Class I · 2014-09-10 · Customed - PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAND COVER REINFORCED LIF ( I) TABLE COVER REINFORCED 50" X 90" LIF…
FDA Device · Class I · 2014-09-10 · Customed - ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEG…
FDA Device · Class I · 2014-09-10 · Customed - Natural-Knee System Patella Bushings Orthopedic surgical instrument
FDA Device · Class II · 2014-09-10 · Zimmer - HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) MAYO STAND COVER REINFORCED (1) U-DRAPE 60" X 70" WIT…
FDA Device · Class I · 2014-09-10 · Customed - SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30" X 30" (2) UTILITY BOWL 16oz (1) TRAY ORGANIZER FULL DEEP (1) SPECIMEN CONTAIN…
FDA Device · Class I · 2014-09-10 · Customed - Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNEC…
FDA Device · Class I · 2014-09-10 · Customed - V5Ms Transesophageal transducers
FDA Device · Class II · 2014-09-10 · Siemens Medical Solutions Usa - OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0 NDL LILO…
FDA Device · Class I · 2014-09-10 · Customed - ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFOR…
FDA Device · Class I · 2014-09-10 · Customed - PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (1) DRAP…
FDA Device · Class I · 2014-09-10 · Customed - Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) CO…
FDA Device · Class I · 2014-09-10 · Customed - Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Car…
FDA Device · Class II · 2014-09-10 · St Jude Medical Cardiac Rhythm Management Division - CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRA…
FDA Device · Class I · 2014-09-10 · Customed - ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1) BAG SUTURE FLORAL (1)…
FDA Device · Class I · 2014-09-10 · Customed - STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) GOWN STANDARD LARGE SMS (3) TOWELS ABSORBENT 15" X 20" UF (1) MAYO…
FDA Device · Class I · 2014-09-10 · Customed - CIRUGIA CARDIOVASCULAR - CASE CART - (1) CIRUGIA CARDIOVASCULAR (PREPARACION) (1) CIRUGIA CARDIOVASCULAR (ENFERMERA CIRCULANTE) (1) CIRUGIA…
FDA Device · Class I · 2014-09-10 · Customed - ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF (2)…
FDA Device · Class I · 2014-09-10 · Customed - Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF (10)GAUZE SPONGE 4…
FDA Device · Class I · 2014-09-10 · Customed - CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP (1) BLADE SURGICA…
FDA Device · Class I · 2014-09-10 · Customed - Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) COUNTER NEEDLE & BLADE 20C FO…
FDA Device · Class I · 2014-09-10 · Customed - Customed O.B. Pack convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clam…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE (1…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11L…
FDA Device · Class I · 2014-09-10 · Customed - CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD (2) PAD OBSTET…
FDA Device · Class I · 2014-09-10 · Customed - UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP (1 0) GAUZE SPONGE 4" X 4" 12 PLY (1) URINARY…
FDA Device · Class I · 2014-09-10 · Customed - Natural-Knee System Patella Bushings Orthopedic surgical instrument
FDA Device · Class II · 2014-09-10 · Zimmer - ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV…
FDA Device · Class I · 2014-09-10 · Customed - Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are i…
FDA Device · Class II · 2014-09-10 · Bio Detek - D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) TRAY MAY…
FDA Device · Class I · 2014-09-10 · Customed - VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS LIF (1) WRAPPER 36" X 36" (1)…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER RE…
FDA Device · Class I · 2014-09-10 · Customed - Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) LITE GLOVES LIF (2) TOWEL ABSORBENT 15" X…
FDA Device · Class I · 2014-09-10 · Customed - UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT. (1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN (1) BAG URINARY DRAING…
FDA Device · Class I · 2014-09-10 · Customed - GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce cathete…
FDA Device · Class II · 2014-09-10 · Galt Medical - NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) ABSORBENT TOWELS 15" X 20" UF (1) LAPAROTOMY T DRAPE 102" X 78" X 12…
FDA Device · Class I · 2014-09-10 · Customed - Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERE…
FDA Device · Class I · 2014-09-10 · Customed - PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1) IMPERVIOUS STOCKINETTE (3) STRIPS TAPE 24" X 4" (1) DRAPE U…
FDA Device · Class I · 2014-09-10 · Customed - ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEE…
FDA Device · Class I · 2014-09-10 · Customed - Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE (1) TOWEL ABSORBENT 15" X 20" (…
FDA Device · Class I · 2014-09-10 · Customed - C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBENT 15" X 20" L/F (1) BABY BLANKET (1 0) GAUZE SPONGE 4" X 4" 16…
FDA Device · Class I · 2014-09-10 · Customed - ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) STOC…
FDA Device · Class I · 2014-09-10 · Customed - NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONG…
FDA Device · Class I · 2014-09-10 · Customed - HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG (1) DRA…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF (1)…
FDA Device · Class I · 2014-09-10 · Customed - OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) DRAPE…
FDA Device · Class I · 2014-09-10 · Customed - PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM
FDA Device · Class II · 2014-09-10 · Zimmer - Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPER…
FDA Device · Class I · 2014-09-10 · Customed - LITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W/7'' CUFF 30" X 42" CSR (1) DRAPE UNDERBUTTOCK WITH POUCH 44" x 35" (…
FDA Device · Class I · 2014-09-10 · Customed - Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (2) TOWELS ABSORBENT 15 X 20 (1) PENCIL C…
FDA Device · Class I · 2014-09-10 · Customed - PHACO PACK - (10) GAUZE SPONGE 4" X 4" 12PLY (2) SYRINGE 3cc W/NDL. 21G X 1 %" (2) MEDICINE CUP 2 oz. (1) OPHTHALMIC DRAPE W/POUCH (1) GOWN…
FDA Device · Class I · 2014-09-10 · Customed
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