23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SimPro™ Now
FDA UDI
Wellspect AB·07333387032443·Single Use Urinary Catheter with water sachet. ...
SimPro™ Now
FDA UDI
Wellspect AB·07392532188497·Single Use Urinary Catheter with water sachet. ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694033701·Low Profile Double Y Plate
DELTA CERAMIC OPTION HEAD DIA2 8
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·April 23, 2018
M2A-38 CUP NONFLARED SZ 58MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 23, 2018
ACT ARTIC E1 HIP BRG 28X38MM S44 DIA28
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·April 23, 2018
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450184400·
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702270501·Elvarex 3/Thigh High/Open Toe-Elephantiasis-Ver...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702595673·E2/AD/OT-E/SFT-ZI/BR
INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL
FDA 510(k)
FDA Class 2
·Cardiovascular
CONDUCTION CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
M2A-38 CUP NON FLARED SZ 56MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 4, 2018
ACT ARTIC E1 HIP BRG 28X38MM S44 DIA28
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 5, 2018
DELTA CERAMIC OPTION HEAD DIA2 8
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·October 4, 2018
LIGACLIP CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 1, 2014
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 17, 2013
CARELINK PROGRAM W/TELEMETRY C
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 16, 2011
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
FDA Enforcement
Class II
·Ongoing·Molnlycke Health Care, Inc·May 24, 2017