12 results
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19ms
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Sources: EU EUDAMED, US FDA
MICROSURGERY KNIFE
FDA 510(k)
FDA Class 1
·Ophthalmic
36M - Marathon Petroleum LS Terminals - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588206189·36M - Marathon Petroleum LS Terminals - Metal
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113409·PS Insert, Size 6 x 18mm
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435060946·MCD Screw 2.0 x 18 mm M1
non lo...
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
FDA 510(k)
FDA Class 2
·Hematology
SaliPen
FDA 510(k)
FDA Class 2
·Dental
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2014
CORTRAK ENTERAL FEEDING TUBE
FDA Adverse Event
Injury
·CORPAK MEDSYSTEMS·Product code KNT·October 29, 2012
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·September 13, 2007
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
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