16 results · 18ms · Sources: EU EUDAMED, US FDA

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MEDCO-SONIC NQ-2000

FDA 510(k)
FDA Class 2 ·Physical Medicine

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600991·Max. 2. Molar band W-Fit left 99

Trimline

FDA UDI
ORMCO CORPORATION·00889989051728·UPPER RIGHT SECOND MOLAR TRIMLINE BAND SIZE 99

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600990501·Max. 2. Molar band W-Fit left 99

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600990051·Max. 2. Molar band W-Fit left 99

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600990101·Max. 2. Molar band W-Fit left 99

S. AUREUS PNA FISH

FDA 510(k)
FDA Class 1 ·Microbiology

CEREC SpeedGlaze

FDA 510(k)
FDA Class 2 ·Dental

CAPSURE SP NOVUS

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·June 10, 2014

UNKNOWN RIGHT HIP STEM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·December 4, 2012

IPLAN STEREOTAXY PLANNING SOFTWARE

FDA Adverse Event
Malfunction ·BRAINLAB AG·Product code HAW·September 21, 2010

OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.

FDA Recall
Terminated ·Ventana Medical Systems Inc·Product code NJT·August 2, 2018

OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic

FDA Recall
Terminated ·Ventana Medical Systems Inc·Product code NJT·December 19, 2017

OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.

FDA Enforcement
Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic

FDA Enforcement
Class I ·Terminated·Ventana Medical Systems Inc·March 7, 2018

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