16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRASEAL XT HYDRO
FDA 510(k)
FDA Class 2
·Dental
Biosens cartridges Light Pink Clear
FDA UDI
PERFLEX LTD·07290110501679·box of 6 identical cartridges sealed in a vacuu...
T-Crystal cartridges Standard Pink
FDA UDI
PERFLEX LTD·07290110500276·Box of 6 identical cartridges sealed in aluminu...
Disc Prep
FDA UDI
Life Spine, Inc.·00190837090012·
T-Crystal cartridges Standard Pink
FDA UDI
PERFLEX LTD·07290110506179·5 identical cartridges sealed in a vacuum bag ;...
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
CEREC3 VITABLOCKS
FDA 510(k)
FDA Class 2
·Dental
TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS
FDA 510(k)
FDA Class 1
·Dental
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code OLO·April 25, 2014
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code NPJ·April 25, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 14, 2013
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·May 25, 2011
LIFEPAK 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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