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