2,306 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NCB Polyaxial Locking Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260520·
Bernafon
FDA UDI
Bernafon AG·05711584086957·ZR3, KIT 312 NFM PB L BE ZERENA 3
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304492240·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776199906·Lletz WGraves Rt Lg ET
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668113189·STERILIZING CASE SMALL KATENA IOP
9.2MHZ PENCIL PROBE 841-A
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787021486·
CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
FDA 510(k)
FDA Unclassified
·Unknown
CRYO-TOUCH II
FDA 510(k)
FDA Class 2
·Neurology
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·March 19, 2021
640G INSULIN PUMP MMT-1712H
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 2, 2021
PUMP MMT-1712KL 640G V4.10 BK SF MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 16, 2021
S-ROM LINER MSER, 28MM, 20 DEG
FDA Adverse Event
Injury
·DEPUY-RAYHAM, A DIVISON OF DEPUY ORTHOPAEDICS, INC.·Product code KWA·October 6, 2008
SPARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·June 20, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 4, 2011
630G INSULIN PUMP MMT-1715K 630G BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·December 1, 2021
NUCLEUS 22
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·April 19, 2021
640G INSULIN PUMP MMT-1711K
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 21, 2021
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 3, 2021
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 2, 2021