16 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADAPT Tissue
FDA 510(k)
FDA Class 2
·Cardiovascular
RMO
FDA UDI
Rmo, Inc.·00885797100054·ORTHO IMPRESSION TRAY KIT ASST OF 10 , MX/MN TRAYS
OsteoMed
FDA UDI
OSTEOMED LLC·00845694007139·2.0/2.4mm Fracture Plate Bending Plier, Ratchet
WATERSTON DISSECTOR FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896061217·WATERSTON DISSECTOR FORCEPS ANGLED JAW
ACUMED
FDA UDI
Acumed LLC·10806378014666·2.7mm x 32.0mm Locking Cortical Screw
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706077·Takahashi Ethmoid Forceps 4-1/2" (11.4cm) shaft...
ACUMED
FDA UDI
Acumed LLC·10806378014673·2.7mm x 32.0mm Locking Cortical Screw
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
FDA 510(k)
FDA Class 2
·Immunology
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
FDA 510(k)
FDA Class 2
·Immunology
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·December 13, 2022
SYRINGE 10ML SALINE FILL CE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·August 1, 2019
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·August 10, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 24, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 1, 2013
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