9 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MINITEK GRAM-POSITIVE BROTH & SET AND

FDA 510(k)
FDA Class 1 ·Microbiology

Tranquil-C™

FDA UDI
NEXUS SPINE, L.L.C.·B6788224870·Cervical Rasp +DS 8x16x13

BIOFIBER SYTURE

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

MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

2CM PERIPHERAL CUTTING BALLOON®

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·May 20, 2014

ASR UNI FEMORAL IMPL SIZE 45

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·August 26, 2010

GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

FDA Enforcement
Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

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