18 results · 29ms · Sources: EU EUDAMED, 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