10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FCG·December 26, 2017
KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-
FDA 510(k)
FDA Class 1
·General Hospital
POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
FDA 510(k)
FDA Class 2
·Physical Medicine
BIOMET CC CRUCIATE TRAY 67MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 14, 2014
PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·June 15, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 21, 2011
ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020
ENDOSKELETON® TCS NO 6 SWIVEL DRIVER
FDA Adverse Event
Malfunction
·TITAN SPINE, LLC·Product code HXX·January 28, 2016
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021