14 results · 33ms · Sources: EU EUDAMED, US FDA

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BASHAW CERVICAL IMMOBILIZER DEVICE

FDA 510(k)
FDA Class 1 ·Physical Medicine

Polishers

FDA UDI
DFS - DIAMON GmbH·04057176159076·Prophylaxis pol. set flame 20pcs

THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope

FDA UDI
THD SPA·08033737710517·The THD SURGY light-scope anoscope is a disposa...

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690192961·Femoral Locating Device Bushing 8 deg

ACUMED

FDA UDI
Acumed LLC·10806378039959·Locking Calcaneal System Plate Caddy

Denovo Dental Band Contouring Plier

FDA UDI
Denovo Dental, Inc.·00810059291591·Denovo Dental Band Contouring Plier

ADP,1,P800,(2) S800,1/4" N,TEKTONE

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828118477·ADP,1,P800,(2) S800,1/4" N,TEKTONE

CORTOSS BONE AUGMENTATION MATERIAL

FDA 510(k)
FDA Class 2 ·Orthopedic

RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

NIM-ECLIPSE® CONTROLLER

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 8, 2014

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·October 17, 2012

RESTORE RECHARGEABLE NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 11, 2010

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021