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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,

FDA 510(k)
FDA Class 2 ·Microbiology

Bur PM2-70 50K Diam C Ø4.0

FDA UDI
Bien-Air Surgery SA·07630055503886·

Digital Analogue RP

FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059074628·

Senti Desktop

FDA UDI
PATH medical GmbH·04260223142505·Senti Desktop device with touchscreen

Dreamprep

FDA UDI
BLEEP, LLC·00850003157023·

Indus®

FDA UDI
SPINEFRONTIER, INC.·00190361001096·Invue Max, Two Level ACP, 33mm

Bicon Impression Component

FDA UDI
BICON, LLC·00813110023711·3.0mm Two-Part Titanium Impression Post and Pla...

PBN HYSTERO-SALPINGOGRAPHY CATHETER SET

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

AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1

FDA 510(k)
FDA Class 2 ·Cardiovascular

IVT DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - CALI·Product code KPE·May 8, 2013

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 18, 2014

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 13, 2011

INSPIRE 6F

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025

RESERVOIR INSPIRE 8

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026

REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+3MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 22, 2021

UNKN. POLARCUP SHELL CEMENTED

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS AG·Product code LPH·June 23, 2022

UNKN. POLARCUP SHELL CEMENTED

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS AG·Product code LPH·June 23, 2022

UNKN. POLARCUP SHELL CEMENTED

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS AG·Product code LPH·June 23, 2022

INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025

INSPIRE HARD VENOUS RESERVOIR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022