22 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486020378·MCK PATELLA RESECTION CLAMP
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481137846·LOCATOR R-Tx Attachment System for Hiossen Impl...
Diamond Burr
FDA UDI
ELLIQUENCE, LLC·00846338002732·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450127230·
FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
FDA 510(k)
FDA Class 2
·Radiology
SLIT LAMP BO 900, BQ 900, BP900
FDA 510(k)
FDA Class 2
·Ophthalmic
VANISHPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES·Product code MEG·April 28, 2017
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 22, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 11, 2014
SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code MEG·August 16, 2021
QUICK CHECK ONE
FDA Adverse Event
DIAGNOSTIC SOLUTIONS, INC.·Product code CFR·May 7, 1997
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 13, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 10, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 19, 2014
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·October 19, 2016
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·August 14, 2016
CA 19-9 ELECSYS E2G
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NIG·April 16, 2021
Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
FDA Enforcement
Class II
·Terminated·Riverpoint Medical, LLC·September 14, 2016
SOLITAIRE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·October 5, 2020