544 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Altus Spine Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
XLIF
FDA UDI
Nuvasive, Inc.·00887517415806·XLIF Forceps, Bipolar Str Extra Long
OsteoMed
FDA UDI
OSTEOMED LLC·00845694006552·1.2mm Screwdriver Shaft, Autodriver
Cotton Trial
FDA UDI
Treace Medical Concepts, Inc.·00810111224154·TMC Cotton Trial, 8mm
ELMED
FDA UDI
ELMED INCORPORATED·00842180149823·CLEANING BRUSH FOR 3 MM TROCAR SLEEVE, EACH
UNIVERSAL NEURO 3
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327455786·TEMPORAL PLATE, SMALL
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
ADAPTER SLEEVES 12/14 +5
FDA Adverse Event
Malfunction
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·June 15, 2022
NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026