18 results · 20ms · Sources: EU EUDAMED, US FDA

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Pounce Thrombectomy System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Mini-Mono®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR72205011·High-Tech-Brackets Edgew. 'N' .022" f. weld. ma...

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540356680·TAP FOR 2.0MM MANDIBULAR LAG SCREWS

ELMED

FDA UDI
ELMED INCORPORATED·00842180107748·5 MM DIA., 26 CM, ELMED LAPAROSCOPE, 30 DEGREE ...

LEONE SPA

FDA UDI
LEONE SPA·08033707022282·CALIBRA BANDS 2ND MOLAR n.SUR 1

INTELLIVUE MULTI MEASUREMENT SERVER X2

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 12, 2019

Mini-Mono®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR72205011001·High-Tech-Brackets Edgew. 'N' .022" f. weld. ma...

Mini-Mono®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR72205010051·High-Tech-Brackets Edgew. 'N' .022" f. weld. ma...

Mini-Mono®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR72205010101·High-Tech-Brackets Edgew. 'N' .022" f. weld. ma...

ArtiSential Laparoscopic Instrument-Electrodes

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

CHAMP CHAMP TRANSIT

FDA 510(k)
FDA Class 1 ·Physical Medicine

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 3, 2014

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 23, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

FREESTYLE LIBRE 2

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·May 7, 2026

The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

FDA Enforcement
Class II ·Ongoing·Ithera Medical Gmbh·February 19, 2025

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

FDA Enforcement
Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021