18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GLIDE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052015893·Meniscus Cutter 4,2
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973851·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970904·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970898·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973141·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973318·
GENESIS DM MODEL: 6053000A1
FDA 510(k)
FDA Class 2
·Cardiovascular
CANDELA SMOOTHBEAM LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151580·14 X 12 CERVICAL TRIALS 42MM 0° LORDOSIS
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151771·14 X 12 CERVICAL TRIALS 42MM 10° LORDOSIS
VANGUARD KNEE SYSTEM CR LIPPED TIBIAL BEARING DCM ARCOM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 12, 2019
AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·October 3, 2014
COMBINATION WRENCH Ø11
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXC·June 3, 2013
UNKNOWN DEPUY STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 22, 2011
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019