36 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NUANCE
FDA 510(k)
FDA Class 2
·Dental
Bur PM2-150 80K Steel Ø4.0 St
FDA UDI
Bien-Air Surgery SA·17630055513752·
Orthopedic manual surgical instrument
FDA UDI
BAUI BIOTECH CO. LTD.·04718005159680·Bone Funnel
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450189924·
Infiniti Plus™ Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436102497·Sterile needle guide with (14 x 29.2cm) telesco...
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046568·
DBEST HCG 2 IU/ML TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARCHIMED REMEDY CERVICAL PLATE
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
QUADRA ASSURA CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013
PROTECTA XT CRT-D
FDA Adverse Event
Death
·IPG MFG SWITZERLAND·Product code NIK·September 19, 2014
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 24, 2011
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
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 16, 2023
CARB-EDGE MAYO SCS 5-1/2 STR
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code LRW·November 26, 2018
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·April 27, 2020
MICRUSFRAME10 6MM X 11.9CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022