109 results
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8ms
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Sources: EU EUDAMED, US FDA
VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT REV 15.0X200MM BWD RT REV 16.5X200MM BWD LT REV 16.5X200MM BWD RT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·March 27, 2013
Segmental fluted stem, 18x250mm bwd, Sterile,
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
FDA Enforcement
Class II
·Terminated·Hitachi Medical Systems America Inc·February 26, 2020
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
FDA Enforcement
Class II
·Completed·Exactech, Inc.·August 18, 2021
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
FDA Enforcement
Class II
·Completed·Exactech, Inc.·August 18, 2021
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
FDA Enforcement
Class II
·Terminated·Medtronic Xomed, Inc.·January 4, 2017
Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D., Item Number/EDI 00236017127, Nonsterile. orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·October 4, 2017
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-28
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-32
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-32
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-22
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-26
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020