8 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
FDA Enforcement
Class III
·Terminated·Stryker Instruments Div. of Stryker Corporation·November 23, 2016
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
FDA Enforcement
Class III
·Terminated·Zimmer Surgical Inc·May 20, 2015
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
FDA Enforcement
Class III
·Terminated·Zeiss, Carl Inc·August 3, 2022
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·April 25, 2018
DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.
FDA Enforcement
Class III
·Terminated·DePuy Orthopaedics, Inc.·May 22, 2013
Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer. For powered surgical instruments.
FDA Enforcement
Class III
·Terminated·Stryker Instruments Div. of Stryker Corporation·May 13, 2015
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
FDA Enforcement
Class III
·Terminated·Invivo Corporation·October 28, 2020
CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
FDA Enforcement
Class III
·Terminated·Terumo Cardiovascular Systems Corporation·October 12, 2016