FDA Device · 2013
FDA Device recalls in 2013
RecallRadar indexes 2,249 FDA Device recall notices published in 2013. By classification: 177 Class I, 1,944 Class II, 128 Class III.
- GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System
FDA Device · Class II · 2013-09-25 · Ge Healthcare - Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or…
FDA Device · Class II · 2013-09-25 · Integra Lifesciences D B A Integra Pain Management - BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis
FDA Device · Class II · 2013-09-25 · Assuramed - Hemoccult II BRAND SENSA elite
FDA Device · Class II · 2013-09-25 · Assuramed - ACL TOP 700 LAS
FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory - ACL TOP 300 and ACL TOP 300 CTS (Japan)
FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory - TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device u…
FDA Device · Class II · 2013-09-25 · Cincinnati Sub Zero Products - TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System…
FDA Device · Class II · 2013-09-25 · Medtronic Sofamor Danek Usa - ACL TOP 700
FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory - C2244.3808, CONELOG Titanium Base CC ¿3.8GH0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to…
FDA Device · Class II · 2013-09-25 · Camlog Usa - Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile
FDA Device · Class II · 2013-09-25 · Synthes Usa Hq - Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length
FDA Device · Class II · 2013-09-25 · Sonogage - GE Healthcare, CARESCAPE Monitor B850
FDA Device · Class II · 2013-09-25 · Ge Healthcare - C2244.3820;, CONELOG Titanium Base CC ¿3.8GH2.0 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to…
FDA Device · Class II · 2013-09-25 · Camlog Usa - OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to…
FDA Device · Class II · 2013-09-25 · Biomet 3i - BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number…
FDA Device · Class II · 2013-09-25 · Spine Smith Holdings - TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - Juno DRF System
FDA Device · Class II · 2013-09-25 · Villa Radiology Systems - POWERWAND Safety Introducer with Extended Dwell Catheter
FDA Device · Class II · 2013-09-25 · Access Scientific - C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to…
FDA Device · Class II · 2013-09-25 · Camlog Usa - OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - GE Healthcare, CARESCAPE Monitor B650
FDA Device · Class II · 2013-09-25 · Ge Healthcare - TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - GE Healthcare, Advantage Workstation, READY View Application
FDA Device · Class II · 2013-09-25 · Ge Healthcare - NX3 Try-In Gel
FDA Device · Class II · 2013-09-25 · Kerr Pentron - ACL TOP CTS
FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory - Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids
FDA Device · Class II · 2013-09-25 · Churchill Medical Systems - ACL TOP 700 CTS
FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory - TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - ACL TOP (Base)
FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory - Responder 5 is a nurse call communication system that connects patients with staff in a hospital
FDA Device · Class II · 2013-09-25 · Rauland Borg - GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 53…
FDA Device · Class II · 2013-09-25 · Ge Healthcare - OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste m…
FDA Device · Class II · 2013-09-25 · Zeppessis Reprocessing - OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - Brilliance CT 6, M/N 728256
FDA Device · Class II · 2013-09-25 · Philips Medical Systems Cleveland - ProTime Microcoagulation System
FDA Device · Class II · 2013-09-25 · Assuramed - King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during…
FDA Device · Class III · 2013-09-25 · King Systems - Central Dressing Change Kit
FDA Device · Class II · 2013-09-25 · Churchill Medical Systems - Device Name: Terino Square Chin-Style II-Medium
FDA Device · Class II · 2013-09-25 · Implantech Associates - Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such
FDA Device · Class II · 2013-09-25 · Laserworld Usa - OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054
FDA Device · Class II · 2013-09-25 · Ebi - Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a…
FDA Device · Class II · 2013-09-25 · Biomet 3i - AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor
FDA Device · Class II · 2013-09-25 · Tornier - TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - ACL TOP 500 CTS
FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory - Outlook ES pump is intended for use with B. Braun Medical Inc
FDA Device · Class I · 2013-09-25 · B Braun Medical - OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - 3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet o…
FDA Device · Class II · 2013-09-25 · 3m Health Care Business - C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abu…
FDA Device · Class II · 2013-09-25 · Camlog Usa - ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in ser…
FDA Device · Class II · 2013-09-18 · Siemens Healthcare Diagnostics - Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chloride Flus…
FDA Device · Class II · 2013-09-18 · Covidien - HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged
FDA Device · Class II · 2013-09-18 · Hemocue Ab - Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush…
FDA Device · Class II · 2013-09-18 · Covidien - Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for o…
FDA Device · Class II · 2013-09-18 · Leica Microsystems Schweiz Ag - Brand Name: Vector TAS 8mm Screw
FDA Device · Class II · 2013-09-18 · Ormco Sybronendo - OPERON D850 Surgical Table Product Usage: Surgical Table
FDA Device · Class II · 2013-09-18 · Berchtold - Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels &
FDA Device · Class I · 2013-09-18 · Siemens Healthcare Diagnostics - ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in seru…
FDA Device · Class II · 2013-09-18 · Siemens Healthcare Diagnostics - Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chloride Flus…
FDA Device · Class II · 2013-09-18 · Covidien - Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser
FDA Device · Class II · 2013-09-18 · Cardiogenesis - KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche…
FDA Device · Class II · 2013-09-18 · Roche Molecular Systems - ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in…
FDA Device · Class II · 2013-09-18 · Siemens Healthcare Diagnostics - Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels &
FDA Device · Class I · 2013-09-18 · Siemens Healthcare Diagnostics - Outlook ES pump is intended for use with B. Braun Medical Inc
FDA Device · Class II · 2013-09-18 · B Braun Medical - Microscan rapID/S panels NC3.12 Sold in Japan only
FDA Device · Class I · 2013-09-18 · Siemens Healthcare Diagnostics - Outlook Safety Infusion System Burette Set
FDA Device · Class II · 2013-09-18 · B Braun Medical - Microscan plus Negative Urine Combo 4 Sold outside of US only
FDA Device · Class I · 2013-09-18 · Siemens Healthcare Diagnostics - AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices
FDA Device · Class II · 2013-09-18 · Sybron Dental Specialties - STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to steri…
FDA Device · Class II · 2013-09-18 · Advanced Sterilization Products - Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881570125 Product Usage: Both 0.9% Sodium Chloride F…
FDA Device · Class II · 2013-09-18 · Covidien - Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 Product Usage: Both 0.9% Sodium Chloride Flush…
FDA Device · Class II · 2013-09-18 · Covidien - "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters
FDA Device · Class II · 2013-09-18 · Edwards Lifesciences - *** 1) Cat. 4341B
FDA Device · Class II · 2013-09-18 · Carefusion 2200 - Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush…
FDA Device · Class II · 2013-09-18 · Covidien - Microscan plus Negative Breakpoint Combo 4 Sold outside of US only
FDA Device · Class I · 2013-09-18 · Siemens Healthcare Diagnostics - Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chloride Flu…
FDA Device · Class II · 2013-09-18 · Covidien - Microscan plus Negative Combo 3 Sold outside of US only
FDA Device · Class I · 2013-09-18 · Siemens Healthcare Diagnostics - Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels &
FDA Device · Class I · 2013-09-18 · Siemens Healthcare Diagnostics - Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053
FDA Device · Class II · 2013-09-18 · Lumenis - BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lake…
FDA Device · Class II · 2013-09-18 · Becton Dickinson And - Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer
FDA Device · Class II · 2013-09-18 · Ge Healthcare - Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for o…
FDA Device · Class II · 2013-09-18 · Leica Microsystems Schweiz Ag - Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlu…
FDA Device · Class II · 2013-09-18 · Xlumena
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