28 results · 27ms · Sources: EU EUDAMED, US FDA

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Healgen® URS Test Strips

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Ophthalmic Forceps

FDA UDI
KATENA PRODUCTS, INC.·00841668106174·PIERSE FORCEPS 0.1MM STRAIGHT

Q-FIX

FDA UDI
Smith & Nephew, Inc.·00885556724606·1.8MM Q-FIX ALL SUTURE ANCHOR

IPL HAIR REMOVAL DEVICE CT05

FDA Adverse Event
Injury ·SHENZHEN CHUANGTONG YIGOU TECHNOLOGY CO., LTD.·Product code OHT·February 19, 2026

HAND-HELD HAIR REMOVAL DEVICE

FDA Adverse Event
Injury ·SHENZHEN CHUANGTONG YIGOU TECHNOLOGY CO., LTD.·Product code OHT·March 9, 2026

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702782721·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...

ceraMotion®

FDA UDI
DENTAURUM GmbH & Co.KG·J011251800150·ceraMotion® Ti 8 Shade Set / dental ceramic mat...

ceraMotion®

FDA UDI
DENTAURUM GmbH & Co.KG·J011251800450·ceraMotion® Ti Chroma Concept Set / dental cera...

IdentiTi

FDA UDI
ALPHATEC SPINE, INC.·00190376383552·LIF, GRAFT CONTAINMENT CLIP, 18MM 0°

ceraMotion®

FDA UDI
DENTAURUM GmbH & Co.KG·J011251800500·ceraMotion® Ti Touch Up Set / dental ceramic ma...

IN6 SAFETY SYRINGE, MODEL 3ML

FDA 510(k)
FDA Class 2 ·General Hospital

Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)

FDA 510(k)
FDA Class 2 ·Dental

Omnia Medical TiBrid™-L

FDA UDI
OMNIA MEDICAL, LLC·00843511106522·LATERAL INTERBODY, 22x45x18mm, 0°

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·August 31, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 14, 2014

PELVICOL 2CM X 7CM 1.0MM

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 18, 2013

BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE

FDA Adverse Event
Malfunction ·VERATHON MEDICAL ULC·Product code EOQ·August 5, 2025

20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 28, 2016

Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).

FDA Enforcement
Class II ·Terminated·Diagnostica Stago, Inc.·September 19, 2018

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

FDA Recall
Open, Classified ·Philips North America·Product code LNH·April 14, 2026