15 results · 25ms · Sources: EU EUDAMED, 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