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