21 results · 23ms · Sources: EU EUDAMED, US FDA

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BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS

FDA 510(k)
FDA Class 3 ·Orthopedic

AVAN TAP CORT SCR SS 4.5X26MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X58MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X48MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X56MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X60MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X20MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X52MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

M2A ACETABULAR COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI

FDA 510(k)
FDA Class 2 ·Anesthesiology

RE-ENTRANT CHAMBER, MODEL 1008 OR 44D

FDA 510(k)
FDA Class 2 ·Radiology

GMK-REVISION FEMUR REVISION PS SIZE 1 R

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·July 9, 2021

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·April 16, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·May 10, 2011

CANCELLOUS SCREW

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code HWC·July 22, 2008

ISODUR PROSTHESIS HEAD 12/14 32MM XL

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 1, 2025

ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog No.REF 06597053, 3) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970555, Catalog No.REF 06597055 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

FDA Enforcement
Class III ·Terminated·Angiodynamics, Inc.·December 28, 2016

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012