15 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Bosworth
FDA UDI
Harry J Bosworth Company·H6680921071·Zinc Phosphate Dental Cement P&L Standard Kit L...
MICASEPT ATRAUMATIC ALLIS GRASPING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896011045·MICASEPT ATRAUMATIC ALLIS GRASPING FORCEPS WITH...
MICASEPT ATRAUMATIC ALLIS GRASPING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·B09920921070·MICASEPT ATRAUMATIC ALLIS GRASPING FORCEPS WITH...
MICASEPT ATRAUMATIC ALLIS GRASPING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896008571·MICASEPT ATRAUMATIC ALLIS GRASPING FORCEPS WITH...
MICASEPT ATRAUMATIC ALLIS GRASPING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896008588·MICASEPT ATRAUMATIC ALLIS GRASPING FORCEPS WITH...
MICASEPT ATRAUMATIC ALLIS GRASPING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·B0992092107004·MICASEPT ATRAUMATIC ALLIS GRASPING FORCEPS WITH...
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
FDA 510(k)
FDA Unclassified
·Unknown
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
FDA 510(k)
FDA Class 2
·Immunology
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·September 21, 2015
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 3, 2013
NEXGEN STEMMED TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER TURPEAUX INDUSTRIAL PARK·Product code JWH·August 21, 2014
NONIN
FDA Adverse Event
Other
·CAREFUSION 211, INC.·Product code DQA·December 13, 2010
CYCLESURE BIOLOGICAL INDICATOR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code FRC·December 30, 2010
STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·December 19, 2012