9 results · 28ms · Sources: EU EUDAMED, US FDA

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TANSEEKER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MONDEAL

FDA UDI
MONDEAL Medical Systems GmbH·04050435063589·MCD Screw 4.0 x 32 mm M3 lockin...

BIODENTINE

FDA 510(k)
FDA Class 2 ·Dental

EmoLED (v. 2-USA)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 30, 2014

RECEPTAL CANISTER 1000 ML CE

FDA Adverse Event
Malfunction ·AMSINO MEDICAL CO., LTD·Product code GCX·November 13, 2012

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 15, 2010

Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.

FDA Enforcement
Class II ·Terminated·Sheffield Pharmaceuticals, LLC·July 8, 2015

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018