10 results
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18ms
·
Sources: EU EUDAMED, US FDA
TENSOPLAST SKIN TRACTION KIT
FDA 510(k)
FDA Class 1
·Orthopedic
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113379·PS Insert, Size 6 x 12mm
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435060915·MCD Screw 2.0 x 12 mm M1
non lo...
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
SULTAN SPOROX TEST VIAL, MODEL 75195
FDA 510(k)
FDA Class 2
·General Hospital
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 2, 2012
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2015
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015