9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TranS1 AxiaLIF Plus System
FDA 510(k)
FDA Class 2
·Orthopedic
AccuQuest
FDA UDI
Bernafon AG·05711584087701·AQ CO3 B 105, 2.4G NFM DPB SABE/MSIL ACCUQ
ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
DISPOSABLE BLOOD PRESSURE CUF
FDA 510(k)
FDA Class 2
·Cardiovascular
FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code OWN·March 5, 2025
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·October 8, 2008
AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·May 1, 2013
CVC SET: 2-LUMEN 12 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code FOZ·July 20, 2011
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014