95 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TENS STIMULATOR, MODELS 2800 AND 3000
FDA 510(k)
FDA Class 2
·Neurology
RHEAD
FDA UDI
Stryker GmbH·00886385024059·Stem Implant 6mm Collar,Size 1
ALL SILICONE FOLEY BALLOON CATHETER
FDA UDI
Sewoon Medical Co., Ltd.·08806369402507·2way/Translucent 30cc 14fr
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193108094·HA PEEK EVOS Straight, ,14mmx8mmx 30mm , FLAT ...
CRYOPEN CRYOSURGICAL SYSTEM, K102214
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450191286·
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
V200 / ESPRIT
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 16, 2021
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 28, 2021
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code MNT·May 19, 2021
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code CBK·May 20, 2021
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code MNT·June 7, 2021
V200 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code CBK·December 9, 2020
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code MNT·June 21, 2021
NORIAN REINFORCED FAST SET PUTTY/3CC
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code GXP·May 19, 2015
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 22, 2013
BIOSTEON WEDGE INTERFERENCE SCREW
FDA Adverse Event
Malfunction
·BIOCOMPOSITES LTD.·Product code HWC·May 20, 2011
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FDI·August 7, 2008
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