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.
- C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX,…
FDA Device · Class II · 2014-09-24 · Varian Medical Systems - Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliqu…
FDA Device · Class II · 2014-09-24 · Genesis Bps - Photonica Light Modulator
FDA Device · Class II · 2014-09-24 · Advanced Photonic Systems - Ultraslim
FDA Device · Class II · 2014-09-24 · Advanced Photonic Systems - Stago IVD, Liquid Anti-Xa, NDC 3607450003116
FDA Device · Class III · 2014-09-24 · Diagnostica Stago - BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separ…
FDA Device · Class II · 2014-09-24 · Fresenius Medical Care Holdings - BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separa…
FDA Device · Class II · 2014-09-24 · Fresenius Medical Care Holdings - Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a dil…
FDA Device · Class II · 2014-09-24 · Beckman Coulter - ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZO…
FDA Device · Class II · 2014-09-24 · Bio Detek - Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of f…
FDA Device · Class II · 2014-09-24 · Genesis Bps - Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister)
FDA Device · Class II · 2014-09-24 · Emg Technology - BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate…
FDA Device · Class II · 2014-09-24 · Fresenius Medical Care Holdings - Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ987…
FDA Device · Class II · 2014-09-24 · Gf Health Products D B A Basic American Metal Products - ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibril…
FDA Device · Class II · 2014-09-24 · Bio Detek - ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282…
FDA Device · Class II · 2014-09-24 · Siemens Healthcare Diagnostics - PROXIMATE Skin Stapler
FDA Device · Class II · 2014-09-17 · Ethicon Endo Surgery - CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic
FDA Device · Class II · 2014-09-17 · Wright Medical Technology - Integra Container Lid, ¿¿ Size, Red
FDA Device · Class II · 2014-09-17 · Integra York Pa - CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE Orthopedic
FDA Device · Class II · 2014-09-17 · Wright Medical Technology - DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile
FDA Device · Class II · 2014-09-17 · Catheter Connections - Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for poste…
FDA Device · Class II · 2014-09-17 · Pioneer Surgical Technology - AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., l…
FDA Device · Class II · 2014-09-17 · Ab Sciex - The BD MAX MRSA Assay, catalogue #442953
FDA Device · Class II · 2014-09-17 · Becton Dickinson And - Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012
FDA Device · Class II · 2014-09-17 · Medtronic Cardiovascular Surgery The Heart Valve Division - RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, sto…
FDA Device · Class II · 2014-09-17 · Radiometer America - CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic
FDA Device · Class II · 2014-09-17 · Wright Medical Technology - CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic
FDA Device · Class II · 2014-09-17 · Wright Medical Technology - Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress, Prime Care ¿ Transcen…
FDA Device · Class II · 2014-09-17 · Primus Medical - CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE Orthopedic
FDA Device · Class II · 2014-09-17 · Wright Medical Technology - CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography
FDA Device · Class II · 2014-09-17 · Coopersurgical - Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand
FDA Device · Class II · 2014-09-17 · Stryker Spine - CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
FDA Device · Class II · 2014-09-17 · Wright Medical Technology - ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer L…
FDA Device · Class II · 2014-09-17 · Baxter Healthcare - CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic
FDA Device · Class II · 2014-09-17 · Wright Medical Technology - CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE
FDA Device · Class II · 2014-09-17 · Ge Healthcare - Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand
FDA Device · Class II · 2014-09-17 · Stryker Spine - CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
FDA Device · Class II · 2014-09-17 · Wright Medical Technology - Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality
FDA Device · Class II · 2014-09-17 · Life Force - Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke
FDA Device · Class II · 2014-09-17 · Concentric Medical - CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
FDA Device · Class II · 2014-09-17 · Wright Medical Technology - Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform
FDA Device · Class II · 2014-09-17 · Illumina - ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adap…
FDA Device · Class II · 2014-09-17 · Baxter Healthcare - ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter wi…
FDA Device · Class II · 2014-09-17 · Baxter Healthcare - BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the…
FDA Device · Class II · 2014-09-17 · Biomet 3i - Siemens Luminos dRF, Ysio or Uroskop Omnia systems
FDA Device · Class II · 2014-09-17 · Siemens Medical Solutions Usa - O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 EO sterilized surgical convenient packs packaged into polyester/pol…
FDA Device · Class I · 2014-09-10 · Customed - EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1)…
FDA Device · Class I · 2014-09-10 · Customed - OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1)…
FDA Device · Class I · 2014-09-10 · Customed - PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15" X 20" UF (1) TOP DRAPE WITH ADHESIVE STD SMS (1) CATHETER NELATON RO…
FDA Device · Class I · 2014-09-10 · Customed - Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUT…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT…
FDA Device · Class I · 2014-09-10 · Customed - Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH TAPE 4…
FDA Device · Class I · 2014-09-10 · Customed - Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy
FDA Device · Class II · 2014-09-10 · Elekta - LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER REINFORCED UF (1) BLADE SURGICAL #11 STAINLESS STEEL…
FDA Device · Class I · 2014-09-10 · Customed - Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" X12' L…
FDA Device · Class I · 2014-09-10 · Customed - BASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50" X 90" UF (4) DRAPE UTILITY WITH TAPE UF (1) TOWEL ABSORBENT 15" x 20" L/F (1) SUTURE…
FDA Device · Class I · 2014-09-10 · Customed - OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBEN…
FDA Device · Class I · 2014-09-10 · Customed - Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauzes…
FDA Device · Class I · 2014-09-10 · Customed - CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN…
FDA Device · Class I · 2014-09-10 · Customed - ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd
FDA Device · Class I · 2014-09-10 · Customed - CYSTO TUR PACK BASIC CODE 900-2899
FDA Device · Class I · 2014-09-10 · Customed - Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE SPONGES 4 X 4 12PL Y (1) SCISSORS IRIS STRAIGHT 4.5 W/P…
FDA Device · Class I · 2014-09-10 · Customed - Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiol…
FDA Device · Class II · 2014-09-10 · Hitachi Medical Systems America - Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" (2) GOWN XLARGE SMS IMPERVIOUS REINFORCED (1) COVER MAYO STAND REIN…
FDA Device · Class I · 2014-09-10 · Customed - ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X…
FDA Device · Class I · 2014-09-10 · Customed - MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORC…
FDA Device · Class I · 2014-09-10 · Customed - CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LID 80oz.…
FDA Device · Class I · 2014-09-10 · Customed - MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS IMPERVIO…
FDA Device · Class I · 2014-09-10 · Customed - ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60…
FDA Device · Class I · 2014-09-10 · Customed - ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd
FDA Device · Class I · 2014-09-10 · Customed - Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM (…
FDA Device · Class I · 2014-09-10 · Customed - REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED…
FDA Device · Class I · 2014-09-10 · Customed - FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) TOWEL ABSORBENT 15" X 2…
FDA Device · Class I · 2014-09-10 · Customed - O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH…
FDA Device · Class I · 2014-09-10 · Customed - Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER REINFOR…
FDA Device · Class I · 2014-09-10 · Customed - FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into polyeste…
FDA Device · Class I · 2014-09-10 · Customed - Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X 24 L/F Product Usage: EO sterilized surgical conve…
FDA Device · Class I · 2014-09-10 · Customed - iTRACK250A Canaloplasty Microcatheter Kit
FDA Device · Class II · 2014-09-10 · Ellex Iscience - ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 21G X 1% ( 1) TABLE…
FDA Device · Class I · 2014-09-10 · Customed - Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor…
FDA Device · Class II · 2014-09-10 · Hill Rom - Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD X-LARGE SET IN SLEEVE (3)…
FDA Device · Class I · 2014-09-10 · Customed - KNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN SURG REINFORCED LARGE TOWEL WRAP AAMI LEVEL Ill (1…
FDA Device · Class I · 2014-09-10 · Customed - PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top
FDA Device · Class II · 2014-09-10 · Zimmer - LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) DRAPE T LAPAROTOMY STD…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T LAPAROSCOPY SMS LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DRAPE…
FDA Device · Class I · 2014-09-10 · Customed - CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HYPODERMIC 18G X 1 % LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LO…
FDA Device · Class I · 2014-09-10 · Customed - PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1) CAUTERY TIP POLISHER LIF (1) BAG SUTURE FLORAL L/F (1) YANKAUER SUCTION TUBE…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWEL 15" X 20" LIF (1) GOWN…
FDA Device · Class I · 2014-09-10 · Customed - PERl GYN PACK (1) TABLE COVER 44" x 90" (2) LEGGINS W/7" CUFF 30" x 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (2) TOWELS ABSORBENT 15" X 20" (1…
FDA Device · Class I · 2014-09-10 · Customed - Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical conve…
FDA Device · Class I · 2014-09-10 · Customed - CESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD LIF (1) UMBILICAL CORD CLAMP LIF (1) COVER TABLE REINFO…
FDA Device · Class I · 2014-09-10 · Customed - OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO LARGE (3) DRESSING NON ADH TELFA 8 X 3 (2) BAG GLASSINE PL…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE UTILITY WITH TAPE (1) TOWELS ABSORBENT 15" X 20" (2) L…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROTOMY PACK 1 (2&3) CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE (1) SUT…
FDA Device · Class I · 2014-09-10 · Customed - OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc W…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPY PREMIUM PACK - (1) TABLE COVER REINFORCED 50" x 90" UF (4) TOWEL ABSORBENT 15" x 20" UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF…
FDA Device · Class I · 2014-09-10 · Customed - FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) PVP TRIPLE SWABSTICK IODO…
FDA Device · Class I · 2014-09-10 · Customed - SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER REINFORCED L/F (1) U-DRAPE 60" X 70" WITH TAPE SPLIT…
FDA Device · Class I · 2014-09-10 · Customed
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