13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EON
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEALIX AWL/TAP
FDA UDI
DEPUY MITEK, LLC·10886705007738·HEALIX Awl/Tap 4.5mm
LCP
FDA UDI
Synthes GmbH·10886982156631·LCP PROXIMAL LATERAL TIBIA PLATE 11 HOLES/260MM...
REVERE STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNK_SMART TOUCH BIDIRECTIONAL SF
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·August 18, 2022
*
FDA Adverse Event
Injury
·SMITH & NEPHEW·Product code KWY·November 5, 2008
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·August 24, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 18, 2019
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·May 28, 2021
THE Q-TRAK SUBCUTANEOUS ELECTRODE
FDA Adverse Event
Injury
·OSCOR INC·Product code LWS·November 21, 2023
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024