50 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SurgiLance® Safety Lancet
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEALIX AWL/TAP
FDA UDI
DEPUY MITEK, LLC·10886705007714·HEALIX Awl/Tap 5.5mm
LCP
FDA UDI
Synthes GmbH·10886982156594·LCP PROXIMAL LATERAL TIBIA PLATE 9 HOLES/220MM-...
Taperloc® Complete Instrument
FDA UDI
Biomet Orthopedics, LLC·00887868508851·
TAPERLOC COMPLETE INSTRUMENT
FDA UDI
Biomet Orthopedics, LLC·00880304509719·
COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SpaceOAR System
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 20, 2023
4K CAMERA HEAD
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·May 1, 2021
4K AUTOCLAVABLE CAMERA HEAD
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·September 13, 2021
ACCU-CHEK ADVANTAGE GTS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS CORP.·Product code CFR·August 10, 2005
TLOC 133 OFFSET INSERTER ASSY
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·October 5, 2022
NAJO REDIHOLD BACKBOARD WITH 10 PINS
FDA Adverse Event
Malfunction
·Product code FPP·November 5, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
PROLENE POLYPROPYLENE MESH
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 12, 2013
IFUSE IMPLANT SYSTEM
FDA Adverse Event
Injury
·SI-BONE, INC.·Product code OUR·July 10, 2017
TLOC 133 OFFSET INSERTER ASSY
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·November 29, 2023
4K CAMERA HEAD
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·July 7, 2021
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code CGN·March 25, 2014
DEEP BRAIN STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·October 23, 2008