10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DGH-3000A A-SCAN
FDA 510(k)
FDA Class 2
·Radiology
GC Initial™
FDA UDI
Gc America Inc.·J0228727261·GC Initial™ IQ/Correction Powder C2-Zr, 5g
GC Initial™
FDA UDI
Gc America Inc.·15400556709884·GC Initial™ IQ/Correction Powder C2-Zr, 5g
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
INSTRUMENTS NONSTERILE & STERILE
FDA 510(k)
FDA Class 1
·Neurology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 15, 2014
X7000 XENON LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·October 12, 2010
EMERGE¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·December 13, 2012
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023