FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

80 results for "Olympus Corporation of the Americas"
49–72 of 80
Search insights Median review: 136d Cleared: 100% Top manufacturer: Olympus Medical Systems Corp. Lead specialty: Gastroenterology & Urology
Cleared Sep 05, 2019
EVIS EXERA III Bronchovideoscope Olympus BF-XT190
K183419 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 269d
Cleared Aug 30, 2019
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable...
K190449 · FET
Olympus Medical Systems Corp.
Gastroenterology & Urology · 186d
Cleared Aug 29, 2019
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
K190744 · HET
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 160d
Cleared Aug 02, 2019
Single Use Cytology Brush BC-205D
K190293 · BTG
Olympus Medical Systems Corp.
Anesthesiology · 172d
Cleared Jul 09, 2019
ENDOSCOPE REPROCESSOR OER-Elite
K190969 · FEB
Olympus Medical Systems Corp.
General Hospital · 88d
Cleared Mar 05, 2019
Olympus Small Intestinal Capsule Endoscope System
K183053 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 123d
Cleared Nov 30, 2018
Single Use Hot Biopsy Forceps FD-231
K173495 · QEC
Olympus Medical Systems Corp.
Anesthesiology · 382d
Cleared Nov 15, 2018
Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
K180668 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 246d
Cleared Oct 04, 2018
Rhino-Laryngo Fiberscope Olympus ENF-GP2
K181240 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 147d
Cleared Apr 30, 2018
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy...
K172726 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 231d
Cleared Apr 02, 2018
Instrument basket, for EndoEYE
K171692 · KCT
Olympus Winter & Ibe GmbH
General Hospital · 299d
Cleared Mar 30, 2018
OLYMPUS URF-V2/V2R
K172246 · FGB
Olympus Medical Systems Corp.
Gastroenterology & Urology · 247d
Cleared Mar 29, 2018
OLYMPUS URF-P6/P6R
K172298 · FGB
Olympus Medical Systems Corp.
Gastroenterology & Urology · 241d
Cleared Mar 13, 2018
Olympus Small Intestinal Capsule Endoscope System
K173459 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 126d
Cleared Dec 07, 2017
Single Use Electrosurgical Snare SD-400
K172734 · FDI
Olympus Medical Systems Corp.
Gastroenterology & Urology · 87d
Cleared Dec 05, 2017
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4...
K172618 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 96d
Cleared Nov 27, 2017
Single Use Retrieval Nitinol Basket V
K170811 · LQR
Olympus Medical Systems Corp.
Gastroenterology & Urology · 255d
Cleared Nov 17, 2017
Single Use Electrosurgical knife
K171158 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 211d
Cleared Oct 17, 2017
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS...
K172817 · FET
Olympus Medical Systems Corp.
Gastroenterology & Urology · 29d
Cleared Oct 13, 2017
Single Use Hot Biopsy Forceps FD-231
K171916 · KGE
Olympus Medical Systems Corp.
Gastroenterology & Urology · 109d
Cleared Jan 19, 2017
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K163069 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 78d
Cleared Nov 22, 2016
Disposal Lens Cleaning Sheath
K153773 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 327d
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