13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEATING TENS/EMS, FT-810R
FDA 510(k)
FDA Class 2
·Neurology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517569950·CoRoent Ant TLIF Ti, 12x13x30mm 8°
PG&E Class B 21 Trauma Burn BBP - OTS
FDA UDI
Certified Safety Manufacturing, Inc.·00766588233086·PG&E Class B 21 Trauma Burn BBP - OTS
Orthopedic Instruments
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258647807·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310223308110·
PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RENAISSANCE 29 STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·August 15, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
2.4MM TI VA-LCP VOLAR RIM DSTL RADIUS PLATE/6H HD/5H SHAFT/LT
FDA Adverse Event
Malfunction
·SYNTHES MEZZOVICO·Product code HRS·September 21, 2015
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018