15 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFLAT-O-BALL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ReLine
FDA UDI
Nuvasive, Inc.·00195377068828·RELINE C Screw, 4.0x26mm MA
TRU UCLA Abutment NP Non-Engaging - GOLD
FDA UDI
STERNGOLD DENTAL LLC·00841549110245·TRU UCLA Abutment NP Non-Engaging - Gold. The ...
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837014605·
STERI-DENT, STERI-SURE
FDA 510(k)
FDA Class 2
·General Hospital
BRAIDED GUIDING INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·May 18, 2024
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·May 18, 2024
CVC KIT: 16 GA X 8IN (20 CM)
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQY·January 3, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
CLEARTRACE 2
FDA Adverse Event
CONMED CORPORATION·Product code DRX·September 29, 2010
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·October 28, 2019
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024