17 results · 22ms · Sources: EU EUDAMED, US FDA

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BAUSCH & LOMB IOL INJECTOR

FDA 510(k)
FDA Class 1 ·Ophthalmic

BIO-MODULAR SHOULDER SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304007352·

5530 3L SYRINGE

FDA UDI
HANS RUDOLPH, INC.·00817136025582·3L 5530 GERATHERM SPEC AL ROD

CapSure® Spine System

FDA UDI
Spine Wave, Inc.·10840642105384·PS3 Screw 8.5mm x 50mm

DOLPHIN 3 FLUID MANAGEMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

JOBST READY-TO-WEAR GAUNTLET

FDA 510(k)
FDA Class 2 ·General Hospital

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 15, 2013

PLMA DVC V11.51 1 R

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·September 17, 2014

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 17, 2011

COMP LOCKING SCREW 4.75X35MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·February 15, 2019

VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 15, 2018

COMP RVRS SHDR GLEN BSPLT +HA

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·February 15, 2019

COMP LOCKING SCREW 4.75X35MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·February 15, 2019

COMP LOCKING SCREW 4.75X20MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·February 15, 2019

COMP LOCKING SCREW 4.75X15MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 15, 2018

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025