23 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CIRCUL8 Luxe DVT Prevention Device
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780835·LEVAMED ACTIVE ANKLE SUP SLVR R V
Comprehensive® SRS
FDA UDI
Biomet Orthopedics, LLC·00880304540378·
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551112433·HALO, 1203-5 VEST LARGE, ACRYLIC LINER, 1211-1 ...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112350·Tap, 7.50mm, Fixed Sleeve
GREENLIGHT XPS LASER SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 16, 2016
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
FDA 510(k)
FDA Class 2
·Hematology
LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
GREENLIGHT XPS LASER SYSTEM
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·February 13, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·October 29, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·August 15, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
GREENLIGHT HPS LASER SYSTEM
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·February 25, 2016
GREENLIGHT XPS LASER SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code GEX·April 6, 2022
TAQPATH COVID-19 COMBO KIT
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)·Product code QJR·July 9, 2021
REFOBACIN REVISION 40 -3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·October 15, 2024
GREENLIGHT XPS LASER SYSTEM
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·August 15, 2017
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025