64 results · 27ms · 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.

Medline Cautery Tip Cleaner

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Anti-D (RH1) IgM+IgG

FDA UDI
DIAGAST·23661562105261·Blood Grouping Reagent, Anti-D (Human/Murine Mo...

ELMED

FDA UDI
ELMED INCORPORATED·00842180187696·5MM,45CM, OPEN-FLAT TIPPED IRRIGATION/SUCTION C...

ELMED

FDA UDI
ELMED INCORPORATED·00198506057069·Westphal gall duct forceps. Curved. Delicate, l...

MODIFICATION TO THE GRIP

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE

FDA 510(k)
FDA Class 3 ·Cardiovascular

VIDAS CMV IGM 30 TESTS

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LKQ·April 30, 2021

VIDAS CMV IGM 30 TESTS

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LKQ·April 30, 2021

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 27, 2022

VIDAS CMV IGM 30 TESTS

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LKQ·March 8, 2021

ALINITY I TOXO IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·March 31, 2026

ARCHITECT TOXO IGG

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·April 27, 2026

ARCHITECT TOXO IGG

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·March 19, 2026

MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination

FDA Enforcement
Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·October 4, 2023

DURALOC CONST LINER 52X28

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·October 22, 2008

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 10, 2011

FORTIFY DR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

ALINITY I TOXO IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·April 8, 2026

ALINITY I TOXO IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·March 4, 2026

ALINITY I TOXO IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·April 2, 2026