16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
FDA 510(k)
FDA Class 2
·Anesthesiology
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006069·2700 2WAY NRBV LG 1.375OD PORT
Lateral Disc Prep
FDA UDI
Life Spine, Inc.·00190837089665·
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08809282816857·
Rod Adjuster
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068714·
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 21, 2020
GEODESIC EEG SYSTEM, MODEL 200
FDA 510(k)
FDA Class 2
·Neurology
SPPHINE PLUS STM 3W DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242333·Universal Joint Tap Size Ø4.5 mm
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 2, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 2, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 5, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025