20 results · 33ms · Sources: EU EUDAMED, US FDA

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FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ZEVO ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019

ZEVO ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018

METAFLEXCOIL

FDA 510(k)
FDA Class 2 ·Radiology

GLOBUS PREMIUM MUSCLE STIMULATOR

FDA 510(k)
FDA Class 2 ·Physical Medicine

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 11, 2013

ARCHITECT ANTI-HCV

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code MZO·July 14, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014

CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 52

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·May 6, 2021

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 7, 2025

MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2020

PROWLER SELECT PLUS 150/5CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRA·May 30, 2023

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE 52

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020

EU 4.5X37MM STENT 12 MM DW TIP

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·March 7, 2023

LZOVERSAFITCUP CC TRIO NO HOLE CUP

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 3, 2019

MPACT ACETABULAR SHELL Ø52 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·August 29, 2018

BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·April 11, 2019

EU 4.5X37MM STENT 12 MM DW TIP

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·December 6, 2022

Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

FDA Enforcement
Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018