Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
145657–145680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 1986
PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE
K860195 · JWY
Austin Biological Laboratories
Microbiology · 29d
Cleared Feb 20, 1986
PANOPTIKON
K860316 · LED
Cytocolor, Inc.
Pathology · 23d
Cleared Feb 20, 1986
NEUTROCOLOR
K860317 · LED
Cytocolor, Inc.
Pathology · 23d
Cleared Feb 20, 1986
MEGACOLOR
K860319 · LED
Cytocolor, Inc.
Pathology · 23d
Cleared Feb 20, 1986
GRANULOCOLOR
K860320 · LED
Cytocolor, Inc.
Pathology · 23d
Cleared Feb 20, 1986
LYSOCOLOR
K860321 · LED
Cytocolor, Inc.
Pathology · 23d
Cleared Feb 20, 1986
NEONATE PERCUSSOR
K860510 · BYI
Ballard Medical Products
Anesthesiology · 9d
Cleared Feb 19, 1986
ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY
K853877 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 155d
Cleared Feb 19, 1986
ENDO-LASE CD 40 FOR DERMATOLOGY
K853901 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 152d
Cleared Feb 19, 1986
UVASORB-400
K854442 · HPX
Optatint, Inc.
Ophthalmic · 106d
Cleared Feb 19, 1986
INTRAOCULAR ELECTROMAGNET
K854870 · HPO
Mira, Inc.
Ophthalmic · 77d
Cleared Feb 19, 1986
ACU-SYRINGE W/WO NEEDLES
K854877 · FMF
Acuderm, Inc.
General Hospital · 75d
Cleared Feb 19, 1986
ANGIO MED DISPOSABLE PRESSURE CONNECTORS
K855078 · KGZ
Angiomed U.S., Inc.
General & Plastic Surgery · 62d
Cleared Feb 19, 1986
FRITCH OPHTHALMIC ENDOSCOPE
K855151 · GDB
Regtec
Gastroenterology & Urology · 55d
Cleared Feb 19, 1986
ENZYNATIC TRIGLYCERIDES REAGENT SET
K855164 · CDT
Sterling Diagnostics, Inc.
Chemistry · 55d
Cleared Feb 19, 1986
PARAMAX COMPREHENSIVE CALIBRATOR
K855199 · JIX
American Dade
Chemistry · 54d
Cleared Feb 19, 1986
REFLECTIVE BLANKET
K860066 · KME
O.R. Concepts, Inc.
General Hospital · 44d
Cleared Feb 19, 1986
URIC ACID REAGENT SET
K860111 · LFQ
Technostics Intl.
Chemistry · 37d
Cleared Feb 19, 1986
NURSERY AMBIENT LIGHT METER
K860120 · FMS
Rocky Mountain Medical Corp.
General Hospital · 37d
Cleared Feb 19, 1986
TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT
K860130 · CDZ
Cambridge Medical Technology
Chemistry · 36d
Cleared Feb 19, 1986
UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE
K860168
Universal Medical Instrument Corp.
General & Plastic Surgery · 33d
Cleared Feb 19, 1986
PHAKOSYSTEMS CT-100 CAUTERY MODULE
K860236 · GEI
Phakosystems, Inc.
General & Plastic Surgery · 27d
Cleared Feb 19, 1986
100% COTTON ABSORBENT TOWEL
K860248 · KKX
Devon Industries, Inc.
General Hospital · 26d
Cleared Feb 19, 1986
REESE ARTHRODESIS SCREW
K860323 · HWC
Osteotomy Guide Co.
Orthopedic · 21d