23 results · 28ms · Sources: EU EUDAMED, US FDA

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INTELLIVUE PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

COMPREHENSIVE SHOULDER SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304470743·

Comprehensive® Shoulder System

FDA UDI
Biomet Orthopedics, LLC·00887868268014·

2100 3 WAY STOPCOCK

FDA UDI
HANS RUDOLPH, INC.·00817136021515·2100C 3WAY STPCK 35OD, 3.2mmHB

CapSure® Spine System

FDA UDI
Spine Wave, Inc.·10840642105056·PS3 Screw 6.5mm x 55mm

MODIFICATION TO: BIOMET HUMERAL CABLE PLATES

FDA 510(k)
FDA Class 2 ·Orthopedic

SAPPHIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

11/13 S-ROM 40MM M SPEC+0

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 15, 2013

TRILOGY 02

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·September 17, 2014

ADVANTAGE SERIES 29

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·May 24, 2011

E1 44-41 STD HMRL BRNG

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·April 21, 2020

COMP RVS TRAY +10MM CO 44MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·April 21, 2020

COMP RVS HMRL TI TRAY 44MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code PAO·April 17, 2017

COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM STANDARD

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code PAO·June 30, 2017

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·August 17, 2023

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·April 8, 2025

TI-SU03 GC

FDA Adverse Event
Injury ·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2026

MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NKM·July 7, 2017

BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022