19 results · 24ms · Sources: EU EUDAMED, US FDA

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Heavy Double Flexible Tipped Wire Guide

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699540·GENUMEDI PSS BLUE SIZE II

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526768468·GENUMEDI PSS GREEN II

BIOMET PATELLAR SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304240230·

Biomet® Patellar System

FDA UDI
Biomet Orthopedics, LLC·00887868241642·

General Instruments

FDA UDI
ALPHATEC SPINE, INC.·00840180525579·14 mm Stopped Awl Bevel Tip

LEONE SPA

FDA UDI
LEONE SPA·08033707071464·MINI ORTHODONTIC IMPLANT HIGH D1,5 L8 mm

MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·December 2, 2024

PHILIPS SONICARE

FDA Adverse Event
Injury ·PHILIPS ORAL HEALTHCARE·Product code JEQ·July 9, 2018

AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·February 21, 2018

ORTHOLOC® DRILL BIT 1/8

FDA Adverse Event
Malfunction ·MICROPORT ORTHOPEDICS INC.·Product code GFG·December 2, 2019

UNKNOWN DEPUY 32MM FEMORAL HEAD

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·October 8, 2014

TRANSFER SET

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 6, 2013

OCTRODE LEAD, 30CM LENGTH

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 21, 2011

SCREWDRIVER

FDA Adverse Event
Injury ·MICROPORT ORTHOPEDICS INC.·Product code HXX·January 24, 2025

AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code JWH·August 25, 2017

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