12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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JAWS Nitinol Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113660·CYSTOTOME STRAIGHT 25GA
GLOBAL CAP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295104926·GLOBAL CAP HUMERAL HEAD TRIAL 56mm x 18mm
GLOBAL CAP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295104933·GLOBAL CAP HUMERAL HEAD TRIAL 56mm x 21mm
PASCAL LASER INDIRECT OPHTHALMOSCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
CIRCUIT TUBINGS WITH X-COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
SETROX S 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·November 4, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·August 10, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024