15 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Carestream Vue PACS
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776369958·Oval Window Pick,
Bausch + Lomb
FDA UDI
Bausch & Lomb Incorporated·00757770436613·PICK OVAL WDW HOUS 30DEG 1/3MM
ELMED
FDA UDI
ELMED INCORPORATED·00842180164932·PICK OVAL WINDOW PICK HOUSE 30DEG .33mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197452823·McCulloch Blade 1 Hook with thorns
80mm long
JEDMED
FDA UDI
JEDMED INSTRUMENT COMPANY·M633301705800·PICK OVAL WINDOW HOUSE 30-DEG .33MM
NASOPHARYNGOSCOPE, BRONCHOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EXSALT WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
VITROS CHEMISTRY PRODUCTS PHYT SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DIP·October 13, 2010
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 14, 2014
STRYKER ORTHOPAEDICS
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS·Product code MEH·May 7, 2013
ACCU-CHEK MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 21, 2011
BD PRECISIONGLIDE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 19, 2020
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·March 17, 2020
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024