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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EndoflipTM 300 System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MIX2VIAL TRANSFER DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
PUMP MMT-522NAL PRDGM INS V2.2 CL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·November 12, 2008
FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·September 1, 2011
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KOG·July 17, 2013
CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·June 8, 2015
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·July 16, 2020
STANDARD INSERTION HANDLE
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code LXH·June 8, 2015
CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·June 8, 2015
8.0MM/4.2MM DRILL SLEEVE 200MM
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code FZX·June 8, 2015
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).
FDA Enforcement
Class II
·Terminated·Sysmex America Inc·November 6, 2013