11 results
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19ms
·
Sources: EU EUDAMED, US FDA
KEY RING ALCOHOL BREATHALYZER
FDA 510(k)
FDA Class 1
·Clinical Toxicology
NA
FDA UDI
STRYKER CORPORATION·04546540877635·Drill Bit SS 3.6mm (9.0/64.0in.) x 84.0mm
PRIMAFLOW
FDA 510(k)
FDA Class 2
·Dental
AQUARIUSNET SERVER
FDA 510(k)
FDA Class 2
·Radiology
SPINNING SPIROS® CLOSED MALE LUER, RED CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·November 4, 2025
INSERTER F/TEN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·April 29, 2013
MAESTRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBB·April 26, 2011
PERMACLIP DISPOSABLE CARTRIDGE, 10MM CLIPS
FDA Adverse Event
Malfunction
·DESIGN STANDARDS CORP·Product code FZP·July 25, 2008
THREADED ROD FOR SMALL F-TOOL
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·July 23, 2019
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012