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

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HY-CHLO(TM)WOUND SCRUB

FDA 510(k)
FDA Class 2 ·General Hospital

7500 V MASK

FDA UDI
HANS RUDOLPH, INC.·00874750000029·7500 SMALL 22OD ELB W/STD HDGR

ZAVATION ROD CONNECTOR

FDA UDI
Zavation LLC·00197157016135·ROD CONNECTOR, PARALLEL CLOSED 12mm OFFSET, Ø 5...

P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)

FDA 510(k)
FDA Class 2 ·Orthopedic

UPD-Y0003

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

TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code JEY·May 31, 2019

CONNECSCR F/INSERTION DHS BLADE

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code LXH·May 15, 2013

DUR MAR NEUT LINER 28IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 20, 2011

TRIATHLON #3 CR INSERT 9MM

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·August 12, 2008

WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code LZD·August 29, 2017

BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HWC·June 3, 2016

ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL

FDA Adverse Event
Malfunction ·MAQUET GMBH·Product code FQO·January 16, 2024

V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use

FDA Enforcement
Class II ·Terminated·Vital Scientific N.V.·October 23, 2019

Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

FDA Enforcement
Class I ·Terminated·Animas Corporation·April 10, 2013

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

FDA Enforcement
Class II ·Ongoing·Abbott Medical·January 1, 2025