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High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
Medical Devices·18 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures
Medical Devices·34 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
Medical Devices·14 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
Medical Devices·29 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures
Medical Devices·68 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Rhino Laryngo scope ENF-VT2
Medical Devices·3,701 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope BF-240
Medical Devices·1,467 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures
Medical Devices·38 affected·Aug 8, 2018
High RiskFDA
Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris El...
Medical Devices·9 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures
Medical Devices·24 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Ultrasonic Bronchoscope BF-UC160F-OL8
Medical Devices·879 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchofiberscope F-1T160
Medical Devices·3,317 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope F-1TQ180
Medical Devices·1,134 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope BF-P240
Medical Devices·2,163 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope BF-XT160
Medical Devices·861 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchofibercope BF-6C240
Medical Devices·197 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
Medical Devices·20 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope BF-Q180
Medical Devices·5,845 affected·Aug 8, 2018
High RiskFDA
Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris El...
Medical Devices·19 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures
Medical Devices·85 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures
Medical Devices·50 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures
Medical Devices·30 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures
Medical Devices·24 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope BF-Q180-AC
Medical Devices·655 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures
Medical Devices·39 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchofiberscope BF-XP40
Medical Devices·817 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
Medical Devices·32 affected·Aug 8, 2018
High RiskFDA
Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris E...
Medical Devices·94 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchofiberscope BF-XP60
Medical Devices·1,296 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope BF-160
Medical Devices·3,948 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchofiberscope BF-XT40
Medical Devices·931 affected·Aug 8, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part ...
Medical Implants·22 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures
Medical Devices·22 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
Medical Devices·153 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures
Medical Devices·20 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures
Medical Devices·12 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures
Medical Devices·27 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures
Medical Devices·19 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Airway Mobilescope MAF-TM
Medical Devices·3,456 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures
Medical Devices·15 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures
Medical Devices·31 affected·Aug 8, 2018
High RiskFDA
Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris E...
Medical Devices·97 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures
Medical Devices·25 affected·Aug 8, 2018
High RiskFDA
Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.
Medical Devices·103 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope BF-1T60
Medical Devices·2,803 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures
Medical Devices·16 affected·Aug 8, 2018
High RiskFDA
Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
Medical Devices·33 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures
Medical Devices·153 affected·Aug 8, 2018