30 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Additive Orthopaedics Hammertoe Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
MAKO SURGICAL CORP.·00848486020446·ACETABULAR REAMER ¿ 45mm
Denovo general purpose dental molar band
FDA UDI
Denovo Dental, Inc.·00810059290570·Denovo general purpose dental molar band - Mand...
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221044853·Unitek(TM) Molar Band General Purpose Narrow Re...
T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060
FDA 510(k)
FDA Class 2
·Radiology
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·December 1, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
GORE DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DYB·October 19, 2020
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 3, 2026
PX400 MICROCATHETER
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code DQY·June 10, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·July 13, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE LTD·Product code FRN·September 16, 2008
GORE® DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DYB·October 6, 2016
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·October 7, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 6, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026