12 results · 20ms · Sources: EU EUDAMED, US FDA

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CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809872361·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...

LIQUIDERM LIQUID ADHESIVE BANDAGE

FDA 510(k)
FDA Class 1 ·General Hospital

OPTICAL INTEGRITY GENERAL SHAPED FIBER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PRISMAFLEX SETS (HF)

FDA Adverse Event
Death ·BAXTER HEALTHCARE CORPORATION·Product code KDI·May 22, 2023

TERUMO CDI 500 BLOOD PARAMETER MONITOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DRY·April 4, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 15, 2011

VITALITY VR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HXX·April 3, 2018

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013