21 results · 27ms · Sources: EU EUDAMED, US FDA

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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