14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCIg60 Infuser
FDA 510(k)
FDA Class 2
·General Hospital
OsteoMed
FDA UDI
OSTEOMED LLC·00842528104125·ExtremiFix Large, Large Screw Percutaneous Inst...
HAcancellous™ PEEK-C
FDA UDI
INNO Holdings, Inc.·M711591619060·HAcancellous PEEK-C, 16L x 19W x 6H x 8°, HA PE...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311619060·
Cadet Cervical Cage
FDA UDI
VALORUS SPINE LLC·00811771034350·Cadet Cervical Cage, 16mm x 19mm x 06mm, 7° Lor...
Cadet Cervical Cage
FDA UDI
VALORUS SPINE LLC·00811771033728·Cadet Cervical Cage, 16mm x 19mm x 06mm, Non-Lo...
CLEARFIL CERAMIC PRIMER
FDA 510(k)
FDA Class 2
·Dental
SHAPE TO FIT COMPRESSION WEAR
FDA 510(k)
FDA Class 2
·General Hospital
ORTHOSIS, SPINAL PEDICLE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code NKB·October 14, 2016
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 10, 2014
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
ELECTRIC MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 20, 2011
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
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