21 results
·
27ms
·
Sources: EU EUDAMED, US FDA
STERNAL BAND
FDA 510(k)
FDA Class 2
·Orthopedic
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300151·Mand. 1. Molar band W-Fit right 15
CHIMAERA Hip Fracture System
FDA UDI
ORTHOFIX SRL·18054242514862·CHIMAERA HFS END CAP L15MM STERILE
Obtura Spartan
FDA UDI
OBTURA SPARTAN ENDODONTICS·00816168020282·Tip CPR-5D Diamond
Obtura Spartan
FDA UDI
Young Innovations, Inc.·00843471100639·Tip CPR-5D Diamond
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482130742·Symmetry® Elevator, Endofacial, 1/2 Curved
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955939174·Percutaneous Transluminal Angioplasty Balloon C...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300150101·Mand. 1. Molar band W-Fit right 15
Sapphire ULTRA Coronary Dilatation Catheter
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955979330·
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938009·Percutaneous Transluminal Angioplasty Balloon C...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300150051·Mand. 1. Molar band W-Fit right 15
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300150501·Mand. 1. Molar band W-Fit right 15
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955936838·Percutaneous Transluminal Angioplasty Balloon C...
SHASER V-MINI HAIR REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATAC PAK PHOSPHORUS REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ARGUS GAMMA CAMERA
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code KPS·December 14, 2010
PFC STEM TRIAL EXTRACT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·January 25, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NIK·July 11, 2014
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
FDA Enforcement
Class II
·Terminated·Superstat Corp·November 28, 2012
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
FDA Recall
Terminated
·Superstat Corp·Product code LMF·October 24, 2012