15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ThermoPro
FDA 510(k)
FDA Class 2
·Physical Medicine
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·10612479258348·AG Collagen Dressings 4x4" (10/bx, 10/cs)
AUTOPULSE® PLATFORM RESUSCITATION
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·February 9, 2022
AUTOPULSE LIFEBAND
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·October 23, 2021
AUTOPULSE® LIFEBAND
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·February 9, 2022
AUTOPULSE® LIFEBAND
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·February 9, 2022
VIEWRAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929066232·Corpectomy, 16Dx18Wx62H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929066546·Corpectomy, 16Dx18Wx62H 6°
7.5CM ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 10, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2011
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·June 6, 2013
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2025
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014