14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TOXICOLOGY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Helix
FDA UDI
Nuvasive, Inc.·00887517147868·Helix Self-Center Tack Tray, Base
TSRH® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978947907·CROSSLINK 810-201 LP CRSLK 5.0MM .675 SS
VistaTablet™ 2.0 RELAY (W/O VCI Box)
FDA UDI
Vital Connect, Inc.·00850490007368·VistaTablet is a tablet which will be running t...
VistaTablet™ 2.0 (Boxed)
FDA UDI
Vital Connect, Inc.·00850490007306·VistaTablet™ 2.0 (Boxed)
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127020322·Neck Trial, Size 1, Lateral
Stryker Interventional Spine iVAS™ Inflator
FDA UDI
ATRION MEDICAL PRODUCTS, INC.·00856877002247·Inflation Device: 14mL, 30atm
EXPLOR RADIAL HEAD PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BAYER ADVIA IMS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMIS CUP IMPACTOR TERMINAL-M10
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·September 6, 2019
PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·February 5, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 9, 2007
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 31, 2012
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021