13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257124598·15-20 MV FOR MEN CLSC CALF STD NAVY III
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502600·FIXATION SCREW 20 MM, TITANIUM
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120403331·Abrasive, green, medium grit
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101413·SS Suture, 4 per sleeve
STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATRION MEDICAL QL FLUID DISPENSING SYRINGE
FDA 510(k)
FDA Class 2
·Cardiovascular
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 8, 2013
QUATTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code GZB·February 15, 2011
ASCENT HEALTHCARE SOLUTIONS
FDA Adverse Event
Malfunction
·ETHICON·Product code GCJ·May 8, 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