11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MectaLock TI Triple Loaded Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Med Spec Boxer Splint
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357235827·
I-STAT KAOLIN ACT TEST
FDA 510(k)
FDA Class 2
·Hematology
ENDO A CLASS
FDA 510(k)
FDA Class 1
·Dental
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·August 5, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 25, 2011
GUARDWIRE TEMPORARY OCCLUSION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC INC.·Product code DXE·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
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012