11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLASTIC ATTACHABLE DUAL PORT
FDA 510(k)
FDA Class 2
·General Hospital
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506089688·Sawyer Rectal Retractor Blade, 7.6 x 2.9cm
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158218192·SPECULUM SAWYER RECTAL 3"X1.125" BLADE 9.75"
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756021555·SHORT LEG SPLINT
Arthrex®
FDA UDI
ARTHREX, INC.·00888867057647·UNIVERSAL GLENOID CORING REAMER, MEDIUM
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
FDA 510(k)
FDA Class 2
·Orthopedic
IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS
FDA 510(k)
FDA Class 2
·General Hospital
SYMBIQ DUALCHAN INF
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 14, 2014
GORE PROPATEN VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DSY·November 24, 2010
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·January 8, 2013
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015