19 results
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30ms
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Sources: EU EUDAMED, US FDA
MONO-LATEX (TM) SLIDE TEST
FDA 510(k)
FDA Class 2
·Immunology
K2-HF OPAQUER powder, O-B3, 20g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38620080·
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177331·Modular Trial, 20 x 15 x 8mm, 7 Deg Lordosis
ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JiveX
FDA 510(k)
FDA Class 2
·Radiology
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/ COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 12, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORORATION·Product code FRN·January 23, 2014
CE INTERMATE LV 100, 24 PACK,50126
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·October 8, 2010
3002 SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 31, 2012
ZIMMER SEGMENTAL POLYETHYLENE INSERT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·October 21, 2019
SEGMENTAL ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·January 23, 2019
QUICK CORE BIOPSY NEEDLE
FDA Adverse Event
Death
·COOK INC·Product code FCG·February 23, 2017
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012