18 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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Eonis SCID-SMA kit
FDA 510(k)
FDA Class 2
·Immunology
Elite HD+ Light Body Normal Set
FDA UDI
ZHERMACK SPA·EZHIC2030350·Addition silicone impression material
Phasix
FDA UDI
Davol Inc.·00801741095382·Phasix ST Mesh, 30 cm x 35 cm (12" x 14"), Rect...
16PW - Burn Relief
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030302·16PW - Burn Relief
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113639·RETROBULBAR NEEDLE 25GA 38MM
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555207203035·6.0 Slot, HF Polyaxial Screw Assembly - Large H...
CLARREN HELMET
FDA 510(k)
FDA Class 2
·Neurology
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
Widex
FDA UDI
Widex A/S·05706069327052·Widex mind440 M4-19 BTE (Charcoal grey (dark g ...
Widex
FDA UDI
Widex A/S·05706069328479·Widex mind330 M3-19 BTE (Charcoal grey ) Teleco...
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 18, 2014
ALAIR BRONCHIAL THERMOPLASTY CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SAN JOSE·Product code OOY·July 2, 2013
BD PLASTIPAK¿ SYRINGES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·June 17, 2022
MAZOR X SYSTEM
FDA Adverse Event
Malfunction
·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012