38 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PADLOCK
FDA 510(k)
FDA Class 2
·Dental
Bernafon
FDA UDI
Bernafon AG·05711584005651·CT5 M, VC PS SF MAC CANTEO 5
HemoCue® Hb 301 Microcuvettes
FDA UDI
Hemocue AB·17311091118148·HemoCue Hb 301 Microcuvettes 4x75 vial
Flexitron
FDA UDI
Nucletron B.V.·08717213026605·Flexitron Transfer Tube for Metal Needles (9)
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code GEI·December 12, 2014
SURESIGNS VS2+ NBP/SPO2/WIRELESS
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code MHX·August 26, 2021
DIRECT CROWN NATURAL 1
FDA 510(k)
FDA Class 2
·Dental
AMEDITECH IMMUTEST DRUG SCREEN COC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Life Instruments
FDA UDI
Life Instrument Corporation·M9307111814020·18" Ring Curette 14mm Str. Dull Both Sides
Life Instruments
FDA UDI
Life Instrument Corporation·M9307111814010·18" Ring Curette 14mm Str. Sharp Both Sides
BULLET Tapered Intervertebral Distractors and Drills
FDA UDI
MEDICAL DESIGNS LLC·M364111814FD1080·BULLET™ Tapered Intervertebral Distractor, 8-12mm
BULLET Tapered Intervertebral Distractors and Drills
FDA UDI
MEDICAL DESIGNS LLC·M364111814FD1060·BULLET™ Tapered Intervertebral Distractor, 6-10mm
BULLET Tapered Intervertebral Distractors and Drills
FDA UDI
MEDICAL DESIGNS LLC·M364111814204·BULLET™ Tapered Intervertebral Drill Collar Set...
BULLET Tapered Intervertebral Distractors and Drills
FDA UDI
MEDICAL DESIGNS LLC·M364111814205·BULLET™ Tapered Intervertebral Drill Collar All...
BULLET Tapered Intervertebral Distractor and Drills
FDA UDI
MEDICAL DESIGNS LLC·M364111814FD1040·BULLET Tapered Intervertebral Distractor, 4-8mm
BULLET Tapered Intervertebral Distractors and Drills
FDA UDI
MEDICAL DESIGNS LLC·M361111814FD20610·BULLET™ Tapered Intervertebral Drill, 6-3mm
BULLET Tapered Intervertebral Distractors and Drills
FDA UDI
MEDICAL DESIGNS LLC·M364111814FD1100·BULLET™ Tapered Intervertebral Distractor, 10-14mm
BULLET Tapered Intervertebral Distractors and Drills
FDA UDI
MEDICAL DESIGNS LLC·M364111814FD1120·BULLET™ Tapered Intervertebral Distractor, 12-16mm
COCR BALL HEAD IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·October 15, 2025
BULLET Tapered Intervertebral Distractors and Drills
FDA UDI
MEDICAL DESIGNS LLC·M364111814FD20810·BULLET™ Tapered Intervertebral Drill, 8-4mm