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High RiskFDA
Roche Molecular Systems, Inc.
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Respiratory Devices·5,430 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·72 affected·Mar 25, 2021
High RiskFDA
Zavation
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
Medical Devices·31 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.
Medical Devices·11 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Medical Devices·516 affected·Mar 25, 2021
High RiskFDA
Zavation
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·7 affected·Mar 25, 2021
High RiskFDA
Zavation
10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.
Medical Devices·58 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·122 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
Medical Devices·195 affected·Mar 25, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Cata...
Diagnostic Devices·143,823 affected·Mar 25, 2021
High RiskFDA
Bard Peripheral Vascular Inc
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 008...
Medical Implants·2,194 affected·Mar 25, 2021
High RiskFDA
Zavation
11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.
Medical Devices·1 affected·Mar 25, 2021
High RiskFDA
Zavation
InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.
Medical Devices·178 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
Medical Devices·7 affected·Mar 25, 2021
High RiskFDA
Medtronic Neuromodulation
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators:  Intellis with...
Medical Implants·79,616 affected·Mar 25, 2021
High RiskFDA
Zavation
InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.
Medical Devices·36 affected·Mar 25, 2021
High RiskFDA
Zavation
11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.
Medical Devices·335 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
Medical Devices·38 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Medical Devices·113 affected·Mar 25, 2021
High RiskFDA
Zavation
VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Medical Devices·140 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
Medical Devices·24 affected·Mar 25, 2021
High RiskFDA
Bard Peripheral Vascular Inc
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 008...
Medical Implants·189 affected·Mar 25, 2021
High RiskFDA
Raysearch Laboratories Ab
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B...
Medical Devices·1 affected·Mar 25, 2021
High RiskFDA
Zavation
InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthope...
Medical Devices·119 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
Medical Devices·98 affected·Mar 25, 2021
High RiskFDA
Zavation
11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
Medical Devices·58 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.
Medical Devices·130 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.
Medical Devices·27 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
Medical Devices·15 affected·Mar 25, 2021
High RiskFDA
Zavation
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.
Medical Devices·2 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.
Medical Devices·162 affected·Mar 25, 2021
CriticalFDA
The Biomed Guys
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alar...
Medical Devices·22 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.
Medical Devices·19 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.
Medical Devices·130 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·72 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021