12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ERMA PC-604 BLOOD CELL COUNTER
FDA 510(k)
FDA Class 2
·Hematology
APPLIED GAUZE SPONGE 2X2X12
FDA 510(k)
FDA Unclassified
·Unknown
DELTA CER HEAD 12/14 36MM +1.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code LZO·October 30, 2012
DELTA CER HEAD 12/14 36MM +1.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code LZO·October 30, 2012
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 30, 2012
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWY·June 25, 2014
HUDSON/MODIFIED TRINKLE ATTACH
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·November 5, 2010
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Malfunction
·REYNOSA MFG·Product code FKX·December 27, 2012
SUMMIT POR TAPER SZ6 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code LPH·April 9, 2015
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 30, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024