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.
- Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physic…
FDA Device · Class III · 2014-08-20 · Agfa Healthcare - Prismaflex TPE 2000 set, Product Number 1071441
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
FDA Device · Class II · 2014-08-20 · Biosound Esaote - Double Offset Rasp Handle, Left Hand Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - Prisma M60 POSTDILUTION set
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide D…
FDA Device · Class II · 2014-08-20 · Biomet - Prisma M100 set
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - Codman Certas - In Line Valve only with SIPHONGUARD¿ Device
FDA Device · Class II · 2014-08-20 · Codman And Shurtleff - Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017
FDA Device · Class II · 2014-08-20 · Medical Positioning - Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewP…
FDA Device · Class II · 2014-08-20 · Integra Lifesciences - Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)
FDA Device · Class II · 2014-08-20 · Zimmer - VI DBL OFFST W/ LRG STPL, LT Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - Prismaflex M100
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option
FDA Device · Class II · 2014-08-20 · Siemens Medical Solutions Usa - Prisma HF1000 preset (new design)
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev
FDA Device · Class II · 2014-08-20 · Ortho Clinical Diagnostics - Prismaflex HF 1000
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories
FDA Device · Class II · 2014-08-20 · Codman And Shurtleff - Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device
FDA Device · Class II · 2014-08-20 · Nellcor Puritan Bennett Dba Covidien - Vl DBL OFFST WI LRG STPL, RT Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - Double Offset Rasp Handle, Left Hand Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories
FDA Device · Class II · 2014-08-20 · Codman And Shurtleff - DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
FDA Device · Class II · 2014-08-20 · Agfa Healthcare - Codman Certas - In Line Valve Only
FDA Device · Class II · 2014-08-20 · Codman And Shurtleff - Prisma TPE 2000 set
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges
FDA Device · Class II · 2014-08-20 · Nanosphere - Prismaflex HF 1400
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative mult…
FDA Device · Class II · 2014-08-20 · Nanosphere - Prismaflex M150
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software…
FDA Device · Class II · 2014-08-20 · Siemens Medical Solutions Usa - Double Offset Rasp Handle, Left Hand Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian RE…
FDA Device · Class II · 2014-08-20 · Medtronic Minimed - 23.5 Deg Rasp Handle Assy- RIGHT Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination…
FDA Device · Class II · 2014-08-20 · Biomerieux - Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784
FDA Device · Class II · 2014-08-20 · Medtronic Neuromodulation - Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system compo…
FDA Device · Class II · 2014-08-20 · Carestream Health - Double Offset Rasp Handle, Right Hand Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories
FDA Device · Class II · 2014-08-20 · Codman And Shurtleff - Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal…
FDA Device · Class II · 2014-08-20 · Beevers Manufacturing And Supply - Enhancement Medical expression. model # EXP-150
FDA Device · Class I · 2014-08-20 · Enhancement Medical - 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System)
FDA Device · Class II · 2014-08-20 · Abbott Molecular - BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry
FDA Device · Class III · 2014-08-20 · Bd Biosciences Systems And Reagents - Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217
FDA Device · Class II · 2014-08-20 · Medical Positioning - Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019
FDA Device · Class II · 2014-08-20 · Medical Positioning - Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length
FDA Device · Class II · 2014-08-20 · Zimmer - Prisma M 100 PRE set
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - VER2 HANDLE, PIN REWORK, RT Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)
FDA Device · Class II · 2014-08-20 · Zimmer - CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003
FDA Device · Class I · 2014-08-20 · Cardiovascular Systems - Double Offset Rasp Handle, Right Hand Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device
FDA Device · Class II · 2014-08-20 · Nellcor Puritan Bennett Dba Covidien - Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories
FDA Device · Class II · 2014-08-20 · Codman And Shurtleff - IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a mul…
FDA Device · Class II · 2014-08-20 · Philips Medical Systems Cleveland - VER2 HANDLE, PIN REWORK, LT Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgic…
FDA Device · Class II · 2014-08-20 · Nidek - Codman Certas - In Line Valve with Unitized Catheter and Accessories
FDA Device · Class II · 2014-08-20 · Codman And Shurtleff - Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit
FDA Device · Class III · 2014-08-20 · Nanosphere - VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
FDA Device · Class II · 2014-08-20 · Medtronic Minimed - 23.5 Deg Rasp Handle Assy- LEFT Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - Double Offset Rasp Handle, Left Hand Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
FDA Device · Class II · 2014-08-20 · Zimmer - Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219
FDA Device · Class II · 2014-08-20 · Medical Positioning - Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally inva…
FDA Device · Class II · 2014-08-20 · Brainlab Ag - PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECi…
FDA Device · Class II · 2014-08-20 · Ortho Clinical Diagnostics - Prisma M 60 PRE set (new design)
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - Radiomat M+ NIF 14 x 17
FDA Device · Class III · 2014-08-20 · Agfa Healthcare - Prisma M100 PRE pump infusion set
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - SIEMENS ADVIA Centaur CP Immunoassay System BNP kit
FDA Device · Class II · 2014-08-13 · Siemens Healthcare Diagnostics - Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitori…
FDA Device · Class II · 2014-08-13 · Icu Medical - VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of anal…
FDA Device · Class II · 2014-08-13 · Ortho Clinical Diagnostics - Serrated Soft Tissue Shields
FDA Device · Class II · 2014-08-13 · X Spine Systems - Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANC…
FDA Device · Class II · 2014-08-13 · Boston Scientific Crm - Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset R…
FDA Device · Class II · 2014-08-13 · Icu Medical - Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use
FDA Device · Class II · 2014-08-13 · Perkinelmer Health Sciences - Latex Dental Dams labeled as Non-Latex Dental Dams
FDA Device · Class II · 2014-08-13 · Coltene Whaledent - KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installe…
FDA Device · Class II · 2014-08-13 · Carestream Health - Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Tri…
FDA Device · Class II · 2014-08-13 · Icu Medical - Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurca…
FDA Device · Class II · 2014-08-13 · Icu Medical - VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of…
FDA Device · Class II · 2014-08-13 · Ortho Clinical Diagnostics - Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated…
FDA Device · Class II · 2014-08-13 · Icu Medical - Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitorin…
FDA Device · Class II · 2014-08-13 · Icu Medical - VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro…
FDA Device · Class II · 2014-08-13 · Ortho Clinical Diagnostics - Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component
FDA Device · Class II · 2014-08-13 · Zimmer - SIEMENS ADVIA Centaur CP Immunoassay System BNP kit
FDA Device · Class II · 2014-08-13 · Siemens Healthcare Diagnostics - Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech
FDA Device · Class II · 2014-08-13 · Stryker Instruments Div - ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for ste…
FDA Device · Class II · 2014-08-13 · Brainlab Ag - INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc
FDA Device · Class III · 2014-08-13 · Carestream Health - Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac…
FDA Device · Class II · 2014-08-13 · Icu Medical - Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc
FDA Device · Class III · 2014-08-13 · Carestream Health - Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring…
FDA Device · Class II · 2014-08-13 · Icu Medical - VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or pla…
FDA Device · Class II · 2014-08-13 · Biomerieux - Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated mo…
FDA Device · Class II · 2014-08-13 · Icu Medical - PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6
FDA Device · Class II · 2014-08-13 · Perkinelmer Health Sciences - AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests
FDA Device · Class II · 2014-08-13 · Advandx - RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730
FDA Device · Class III · 2014-08-13 · Teleflex Medical - RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical
FDA Device · Class II · 2014-08-06 · Teleflex Medical - Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing
FDA Device · Class II · 2014-08-06 · Novocol
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