18 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CORDIS INTRODUCER GUIDE
FDA 510(k)
FDA Class 2
·Cardiovascular
Endo-Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964010888·Endo Carry-on Procedur Kit contains all of the ...
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950018345·FORCEP TISSUE #33 SEMKIN TAYLOR STR 1X2 TEETH 5...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001136·artVeneer life upper anteriors, BL, A4
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 26, 2026
CURE LP
FDA UDI
MEDITECH SPINE, LLC·B167900011360·
CURE LP
FDA UDI
MEDITECH SPINE, LLC·B167S1900011360·
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
FDA 510(k)
FDA Class 2
·Microbiology
MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000
FDA 510(k)
FDA Class 2
·General Hospital
SILK SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAP·July 12, 2018
iBOT PMD with software version 01.05.24. Personal Mobility Device.
FDA Enforcement
Class II
·Ongoing·Mobius Mobility LLC·June 18, 2025
SIG MOD TIB TRAY CEM COCR 2.5
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code JWH·March 13, 2013
FIXODENT DENTURE ADHESIVE, ORIGINAL (CALCUIM ZINC GANTREZ SALT 33%, CELLULOSE GU
FDA Adverse Event
Other
·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·February 18, 2011
SPACEMAKER BLUNT TIP TROCAR 12MM
FDA Adverse Event
Malfunction
·PONCE - USS·Product code GCJ·February 15, 2008
FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO)
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HRX·September 6, 2022
Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code IWJ·November 15, 2007
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018