12 results · 21ms · Sources: EU EUDAMED, US FDA

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COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814275·GENUMEDI PT SILVER R IV

Headless Compression Screw

FDA UDI
I.T.S. GmbH·09120047297544·Headless Compression Screw, Cannulated, D=4.3mm...

10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)

FDA 510(k)
FDA Class 2 ·Radiology

ELECTROPULSE-COSMETIC

FDA 510(k)
FDA Class 2 ·Neurology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 7, 2025

POWERHEART G5 AUTOMATIC AED

FDA Adverse Event
Malfunction ·CARDIAC SCIENCE CORPORATION·Product code MKJ·October 18, 2018

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 6, 2014

LYNX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013

SECURE 3 MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·June 3, 2011

Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

FDA Enforcement
Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015