39 results
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36ms
·
Sources: EU EUDAMED, US FDA
GUARDIAN CONNECTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bur PM2-150 80K Steel Ø3.1 St
FDA UDI
Bien-Air Surgery SA·17630055513769·
Preat
FDA UDI
Preat Corporation·00842092108000·Preci Ball PVC Spacer
CRYOPEN CRYOSURGICAL SYSTEM, K102214
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Infiniti Plus™ Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436102473·Sterile needle guide with (14 x 29.2cm) telesco...
AMP
FDA UDI
ALPHATEC SPINE, INC.·00190376285719·LIF AMP TEMPLATE, 1214
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·August 2, 2019
CG FUTURE BAND
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 15, 2018
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 8, 2019
QUADRA ASSURA CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·May 24, 2011
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 13, 2019
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021
HEMOPRO 2 ADAPTOR
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·February 21, 2020
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 16, 2023
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·April 27, 2020