13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIRION Lateral Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Wrist Lacer II
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357233359·
Kitazato ET Catheter
FDA UDI
KITAZATO CORPORATION·04580745041132·
VARIAX
FDA UDI
Stryker GmbH·04546540541024·SCREW REMOVAL BLADE 2.3, DENTAL
ATRAMAT
FDA UDI
Internacional Farmacéutica, S.A. de C.V.·07500142080531·ATRAMAT SILK SURGICAL SUTURE BLACK USP 3-0 EP 2...
QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
FDA 510(k)
FDA Class 2
·Hematology
SUNRAY FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PULVIGNER·Product code FNL·August 15, 2011
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
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
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026