24 results · 19ms · Sources: EU EUDAMED, US FDA

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POLY-CARB

FDA 510(k)
FDA Class 2 ·Dental

OCTAGON Infinity BL NC Basic screw, L 7.85 mm

FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50220301·BL NC Basic screw, L 7.85 mm for OCTAGON Infini...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694018630·2.0mm x 30mm Lag Screw

Silverbolt/Mainframe

FDA UDI
Choice Spine, LP·10885862163684·

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710410220300·Anterior Closing Wedge Osteotomy Guide, 22mm x ...

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710420220300·Anterior Lateral Closing Wedge Osteotomy Guide,...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694066686·HPS 2.0 x 30mm Lag Screw Sterile Qty 5

PORTABLE INTENSIVE CARE UNIT

FDA 510(k)
FDA Class 3 ·Cardiovascular

OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

3.0MM HEX DRIVER

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code LXH·September 11, 2025

BHR

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·March 26, 2013

SM204 M-SERIES W/BIG WHEEL

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·March 10, 2011

DEEP BRAIN STIMULATION LEAD

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 31, 2008

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·July 14, 2025

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·VANTIVE US HEALTHCARE LLC·Product code KDJ·April 14, 2025

3.0MM DRILL BIT

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HTW·December 21, 2020

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 15, 2025

Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24

FDA Enforcement
Class II ·Ongoing·ICU Medical Inc.·September 10, 2025

MEDTRONIC TRANSCATHETER VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 2, 2022

LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 25, 2025