18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CELOX RAPID GAUZE
FDA 510(k)
FDA Unclassified
·Unknown
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306802911·Reynolds Transauxillary Breast Dissector, 30cm
Utrecht Interstitial Fletcher CT/MR Applicator
FDA UDI
Nucletron B.V.·08717213035119·Interstitial Ovoid Pair 40mm, R15
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450293027·
DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DUO-DENT DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 25, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022
MEDFUSION 3500 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·July 9, 2022
REVITAN, RASP, DISTAL, CURVED, 14/140
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 11, 2018
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
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 7, 2015