21 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAMMOMAT INSPIRATION PRIME
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138127487·BICRO KNEE IMMOBILIZER W/PATELLA STRAP 20IN UN
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376657165·PROXIMITY VA SELF-DRILL SCREW, 3.5 x 20mm
Atoll™
FDA UDI
Seaspine Orthopedics Corporation·10889981052379·3.5mm x 20mm Poly Screw Assm. The Atoll OCT Spi...
Sochi
FDA UDI
Altus Spine, LLC·00843210166483·Polyaxial Screw, 3.5mm x 20mm
Segmental Plating System
FDA UDI
ALPHATEC SPINE, INC.·00190376536217·SPS VA Self-Drill Screw, 3.5 x 20 mm
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
FDA 510(k)
FDA Class 2
·Cardiovascular
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 26, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 24, 2025
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 24, 2025
ARTIS Q ZEEGO
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·December 10, 2024
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 19, 2025
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 6, 2024
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013