15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cold Sore Device (Model: QPZ-01)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Richard-Allan® Needle 1/2 Circle Taper
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113217106·Intent to be used with suture material for tiss...
HEALIX PEEK ORTHOCORD
FDA UDI
Medos International Sàrl·10886705007530·HEALIX PEEK Anchor w/ORTHOCORD PEEK Anchor (1) ...
DISPOSABLE N-PE MICROKERATOME BLADES
FDA 510(k)
FDA Class 1
·Ophthalmic
EXINI
FDA 510(k)
FDA Class 2
·Radiology
NOVASURE
FDA Adverse Event
Malfunction
·CYTYC LTD. PARTNERSHIP·Product code MKN·November 5, 2008
ACCU-CHEK ® AVIVA
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·August 24, 2011
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·July 12, 2013
SERVO-S BASE UNIT
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·September 23, 2025
4.5 HEALIX PEEK ANCH.W/OCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 30, 2019
4.5 HEALIX PEEK ANCH.W/OCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 30, 2019
VERSALOK ANCHOR WITH ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code HWC·March 5, 2017
4.5MM HEALIX PEEK ANCHOR W/ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MAI·March 4, 2017
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025