14 results
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33ms
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Sources: EU EUDAMED, US FDA
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