21 results · 19ms · Sources: EU EUDAMED, US FDA

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VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

FDA 510(k)
FDA Class 2 ·Immunology

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040013090·Zirlux 16+ C3 98.5X10

Kwire tip protector Dia 0.8/1.0 mm sterile

FDA UDI
IN2BONES·03760225714751·Kwire tip protector Dia 0.8/1.0 mm sterile

Intess L

FDA UDI
Kalitec Direct LLC·B07312K0100310·Assembly,Caddie, Lumbar Implants, Hinged

Matira

FDA UDI
Kalitec Direct LLC·B073DRK010031·Drill Guide, Straight, Featureless, Amann

CATHERINE MALANDRINO

FDA UDI
FGX INTERNATIONAL INC.·00193033219201·

CATHERINE MALANDRINO

FDA UDI
FGX INTERNATIONAL INC.·00193033218990·

Inseption

FDA UDI
Kalitec Direct LLC·B07314K0100310·Assembly, Caddie, ISP Implants, Hinged

CATHERINE MALANDRINO

FDA UDI
FGX INTERNATIONAL INC.·00193033219003·

CATHERINE MALANDRINO

FDA UDI
FGX INTERNATIONAL INC.·00193033219010·

URANUS, COMFORTOUCH LASER SYSTEM

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

NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

KIT IMPLANTABLE SLIM TIP LEAD, 90CM

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code PMP·October 19, 2025

VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT

FDA Adverse Event
Malfunction ·SYNTHES ELMIRA·Product code MQP·February 20, 2013

EGIA ULTRA UNIVERSAL SHORT STAPLER

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SUR·Product code GDW·March 11, 2013

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·March 8, 2011

PASSIVE PLUS DX

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

VOYAGER RX CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·May 1, 2008

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

FDA Enforcement
Class II ·Ongoing·CooperSurgical, Inc.·November 24, 2021