14 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
A.S.A.P.® All Surface Access Polishers 6-Pack Refill (Small)
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003074·Dental polishing point
A.S.A.P.® All Surface Access Polishers 6-Pack Refill (Small)
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172012904·Dental polishing point
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742112879·LYNX Distal Tibial Antero Lat Locking Plate, Ti...
IQVITALS AND IQVITALS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NANMA VACUUM PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·April 14, 2021
PEN NDL 31GA 5MM 100BX 1200 USA
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 23, 2021
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 8, 2019
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2013
CONCERTO CRT-D DR AT
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·June 16, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·August 21, 2008
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
FDA Enforcement
Class II
·Terminated·Tenex Health Inc·May 14, 2014