18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1
FDA 510(k)
FDA Class 2
·General Hospital
BI-ANGULAR / BI-POLAR SHOULDER
FDA UDI
Biomet Orthopedics, LLC·00880304002722·
JOBST forMen Casual
FDA UDI
BSN MEDICAL, INC.·00035664131418·FM CASUAL 30-40 KH CT M KKI 1 EN FR ES
Oticon
FDA UDI
Oticon A/S·05707131233820·GET, BTE 13 CNB
NEO / Kinetic Anterior Cervical Plate System
FDA UDI
Life Spine, Inc.·00190837036461·All In One Drill Guide
LOW ADHERENT AFM AG DRESSINGS
FDA 510(k)
FDA Unclassified
·Unknown
MICROGYN PLUS STIMULATION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PAGEWRITER TC 20 CARDIOGRAPH
FDA Adverse Event
Malfunction
·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·November 2, 2024
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 9, 2013
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
PERCEPT
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 4, 2020
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 4, 2025
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025