15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterile Hypodermic Syringe for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
PPS PI
FDA UDI
PEROUSE MEDICAL·03661234011476·Pressure Injectable Safety Huber Needle
NA
FDA UDI
Synthes GmbH·10886982152145·5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252252115·2.0MP LEFORT I PLATE,7MM ADVANCEMENT,R
ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530
FDA 510(k)
FDA Class 2
·Anesthesiology
Materialise PKA Guide System
FDA 510(k)
FDA Class 2
·Orthopedic
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·March 26, 2024
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·October 30, 2014
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 15, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013
DEKA LIPOAI
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 27, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023