21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAUTILUS DELTA
FDA 510(k)
FDA Class 2
·General Hospital
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304425804·
OsteoMed
FDA UDI
OSTEOMED LLC·00842528100127·1.6mm Driver Stem w/Post, Long, Hex
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613021474·Friesner Ear Knife, Screw On Safety Cap
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
FDA 510(k)
FDA Class 2
·General Hospital
XENON(TM) PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025
SEMI-ELEC SNGLE CRANK HI/LO 9153638224
FDA Adverse Event
Death
·INVACARE FLORIDA·Product code FNL·January 2, 2019
AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929034972·Corpectomy, 14Dx16Wx34H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929035146·Corpectomy, 14Dx16Wx34H 6°
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2025
AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026
AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026
ANCHOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 24, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008