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