FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

86 results for "Olympus Corporation of the Americas"
73–86 of 86
Search insights Median review: 136d Cleared: 100% Top manufacturer: Olympus Medical Systems Corp. Lead specialty: Gastroenterology & Urology
Cleared Nov 22, 2016
Disposal Lens Cleaning Sheath
K153773 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 327d
Cleared Apr 21, 2016
ULTRA Telescopes
K160249 · HRX
Olympus Winter & Ibe GmbH
Orthopedic · 80d
Cleared Apr 05, 2016
ULTRA Telescopes
K153009 · EOB
Olympus Winter & Ibe GmbH
Ear, Nose, Throat · 174d
Cleared Mar 22, 2016
Single Use Aspiration Needle NA-U401SX
K160098 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 63d
Cleared Mar 02, 2016
Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
K160241 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 30d
Cleared Feb 12, 2016
Single Use Injector NM600/610
K153625 · FBK
Olympus Medical Systems Corp.
Gastroenterology & Urology · 56d
Cleared Jan 15, 2016
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
K143153 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 438d
Cleared Nov 24, 2015
OES ELITE Telescopes, Protective Tube
K151191 · FBP
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 204d
Cleared Nov 20, 2015
Single Use Aspiration Needle NA-U200H
K151738 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 147d
Cleared Oct 08, 2015
Single Use Balloon Dilator V (with Knife)
K150142 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 259d
Cleared Oct 01, 2015
VISERA 4K UHD SYSTEM
K151011 · HET
Olympus Medical Systems Corp.
Obstetrics & Gynecology · 169d
Cleared Feb 27, 2015
Single Use Biliary Balloon Dilator
K143303 · FGE
Olympus Medical Systems Corp.
Gastroenterology & Urology · 101d
Cleared Feb 08, 2015
ENDOCAPSULE SOFTWARE 10
K142680 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 142d
Cleared Aug 07, 2014
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO...
K133538 · NWB
Olympus Corporation of the Americas
Gastroenterology & Urology · 262d