14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304008519·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515019676·Mixter, fine point, 30 deg, 7" (18cm)
PENTATRASFU BLOOD TRANSFUSION SETS
FDA 510(k)
FDA Class 2
·General Hospital
CABLECAP MODEL: WLF, STZ, ACM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·November 7, 2019
SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·December 19, 2017
TECNIS SYMFONY TORIC
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code POE·February 5, 2018
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ASR ACETABULAR IMPLANT 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 22, 2011
TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code LJS·October 1, 2018
TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code LJS·October 1, 2018
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026