20 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCUSOM
FDA 510(k)
FDA Class 2
·Anesthesiology
JOBST ActiveWear
FDA UDI
BSN MEDICAL, INC.·00035664104863·ACTIVE WEAR 15-20 MM HG KNEE HIGH CLOSED TOE EX...
TRESTLE LUXE
FDA UDI
ALPHATEC SPINE, INC.·00190376215327·TRESTLE LUXE II, ACP, 4-LEVEL, 86
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
GALAXY G3 XSFT 3.5MM X 7.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·April 25, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008
GALAXY G3 MINI 1MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 MINI 1MM X 2CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 MINI 2MM X 6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 XSFT 3MM X 6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024