25 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
FDA 510(k)
FDA Class 2
·Neurology
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·December 11, 2015
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664012953·SOSOFT 30-40 MM HG KNEE HIGH RIB EXTRA LARGE WH...
N/A
FDA UDI
Tyber Medical, LLC·M695M1203300·
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584900·Apex Tibial Nail Ø 12 x 330mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197034081·Lahey Scissors
curved...
DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS)
FDA 510(k)
FDA Class 2
·Anesthesiology
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Truliant
FDA UDI
Exactech, Inc.·10885862314895·Truliant PS Porous Femoral
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 30, 2020
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·April 4, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 16, 2025
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 8, 2022
CONMED HAND CONTROLLED BOVIE
FDA Adverse Event
CONMED·Product code GEI·November 29, 2012
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 2, 2011
TRULIANT POR TIB TRAY SIZE 3F/3T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 24, 2024
TRULIANT TIB IMP PS INSERT SZ 3 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 27, 2022
TRULIANT TIB IMP PS INSERT SZ 3 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 30, 2023