17 results
·
28ms
·
Sources: EU EUDAMED, US FDA
NOVOSTE VESSEL DILATER
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDO-SCRUB®
FDA UDI
MEDTRONIC XOMED, INC.·20643169437177·SHEATH 1912050 5PK ES2 LINVATEC 4MM/0DEG
ENDO-SCRUB®
FDA UDI
MEDTRONIC XOMED, INC.·20613994662013·SHEATH 1912050 5PK ES2 LINVATEC 4MM/0DEG
Penrose Drain
FDA UDI
C. R. Bard, Inc.·00801741051272·Penrose Drain 12" (304.8mm), X-Ray Opaque Rubbe...
JuggerKnot Soft Anchors
FDA UDI
Biomet Orthopedics, LLC·00880304508590·
Reprocessed 4mm EndoScrub Sheath, 0 deg
FDA UDI
SURETEK MEDICAL·B39019120501·
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0120500·Screwdriver, Assembled Screws SNI1
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0120500·Inserter, All-In-One
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
INFUS. SETS-9120-50 CM & 9121-100 CM,EXT
FDA 510(k)
FDA Class 2
·General Hospital
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·December 1, 2010
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 11, 2013
UNKNOWN DEPUY SZ. 32 +1 METAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code KXA·July 3, 2014
JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 1, 2016