12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
FDA 510(k)
FDA Class 2
·General Hospital
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502655·FIXATION SCREW 30 MM, TITANIUM
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257124635·15-20 MV FOR MEN CLSC CALF STD NAVY VII
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101451·SS Suture, 4 per sleeve
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MTP DISPOSABLE TROCAR VALVES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VELA VENTILATOR
FDA Adverse Event
Injury
·CAREFUSION·Product code CBK·August 22, 2014
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code GZB·February 15, 2011
GLOBAL AP EXTRACTION HANDLE
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·January 21, 2008
6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018
6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018