16 results · 32ms · Sources: EU EUDAMED, 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