23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Diode Laser Therapy Systems
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Audina
FDA UDI
Bernafon AG·05711584086452·CAPTO 5 B 105, 2.4G NFM DPB ANBR AUDIN
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199199·AK3 Congruent Insert Trial Size 6, 11mm
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191611801·IN-OVATION® mini EURO 018/L 1 & 2 -6T 0A
RELAY POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076331645·Rasp, 19x16mm, 11mm height, 6-degree
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330303·3D Porous Titanium Cervical Interbody, 19x16mm,...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076336343·Rasp, 19x16mm, 11mm height, 12-degree
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076336909·Rasp, 19x16mm, 11mm height, 12-degree stopless
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076335780·3D Porous Titanium Cervical Interbody, 19x16mm,...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076336060·Trial, 19x16mm, 11mm height, 12-degree
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330624·3D Porous Titanium Cervical Interbody, 19x16mm,...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076336626·Trial, 19x16mm, 11mm height, 12-degree stopless
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330990·Trial, 19x16mm, 11mm height,
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076331317·Trial, 19x16mm, 11mm height, 6-degree
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014
TOTAL ASR ACET IMP SIZE 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·June 26, 2013
SM104 M-SERIES W/5TH WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 1, 2011
ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
FDA Enforcement
Class II
·Terminated·Cenorin, LLC·August 23, 2017