12 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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Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
FDA 510(k)
FDA Unclassified
·Unknown
NA
FDA UDI
Richard Wolf GmbH·04055207048634·SUCT./IRRIG.TUBE SET CARE-LOCK L 3M PVC, PACK=...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045605·PrimaLIF LLIF PEEK Implant, 9mm X 26mm X 55mm, ...
ANYRIDGE INTERNAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ACID ETCHED LAG SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
ENDURO MENISCAL COMPONENT F2 22MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014
ENDURO MENISCAL COMPONENT F2 10MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 14, 2013
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 14, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 30, 2011
ENDURO MENISCAL COMPONENT F1 10MM
FDA Adverse Event
Injury
·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018