12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BMR 1900 PHISIO
FDA 510(k)
FDA Class 2
·Cardiovascular
Wrist Lacer II
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357233618·
Orthopedic Instruments
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258644080·
ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
SENSITHERM PROBE
FDA Adverse Event
Injury
·FIAB S.P.A.·Product code FLL·July 10, 2023
4.5MM CURVED BROAD LCP® PLATE 14 HOLES/265MM
FDA Adverse Event
Malfunction
·SYNTHES GRENCHEN·Product code HRS·November 4, 2014
HUBER NEEDLE
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS, INC.·Product code FPA·August 17, 2011
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·January 13, 2022
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