13 results
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9ms
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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
Segmental fluted stem, 18x250mm bwd, Sterile,
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
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, 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
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
FDA Enforcement
Class II
·Ongoing·EMD Millipore Corporation·March 6, 2024
Lugol s Iodine Solution 500ML, Part Number 624-71
FDA Enforcement
Class II
·Ongoing·EMD Millipore Corporation·December 6, 2023
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·July 15, 2015