30 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIPI BLOCK
FDA 510(k)
FDA Class 2
·Dental
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664009854·BSTRNG 20-30 ARMSLV KNITWLT 1R NAT 1 EN
Infiniti Plus Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436120040·Sterile needle guide (12-18ga) with (14x147cm) ...
TRANSLUX ENERGY
FDA 510(k)
FDA Class 2
·Dental
THERMAL CAUTERY UNIT, MODEL 150
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 2, 2024
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 25, 2022
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·February 23, 2024
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code MGB·February 13, 2024
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 9, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
Malfunction
·DOLOMITE AB·Product code ITJ·September 19, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·May 18, 2011
QUADRA-H CEMENTLESS STEM SIZE 7 LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·January 15, 2016
UNKNOWN PEEK INTERFERENCE SCREW
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·October 20, 2022
UNKNOWN MANUAL INSTR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code NBH·October 17, 2022
XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·April 3, 2015
XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·April 3, 2015
XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·April 3, 2015
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 13, 2026
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025