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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
158809–158832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1983
SOPHEIA THYROXINE EIA KIT
K823751 · KLI
Diagnostic Products Corp.
Chemistry · 29d
Cleared Jan 12, 1983
ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082
K823756 · CIC
Em Industries, Inc.
Chemistry · 29d
Cleared Jan 12, 1983
VARIOUS-ANALYZER CUPS
K823762 · JJE
Cordis Corp.
Chemistry · 29d
Cleared Jan 12, 1983
LUNDIA 10-5-L PARRALLE FLOW DIALYZER
K823791 · KOC
Gambro, Inc.
Gastroenterology & Urology · 27d
Cleared Jan 12, 1983
CAPILLARY FLOW DIALYZERS
K823826 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Jan 12, 1983
INFUSE-A-PORT
K823838 · LJT
Infusaid Corp.
General Hospital · 15d
Cleared Jan 12, 1983
PHADEBAS RAST ALLERGEN DISCS
K823841 · DGC
Pharmacia, Inc.
Immunology · 22d
Cleared Jan 12, 1983
PHADEZYM RAST ALLERGEN DISCS
K823842 · DGC
Pharmacia, Inc.
Immunology · 22d
Cleared Jan 12, 1983
ADVANCE EMIT CAD LIDOCAINE ASSAY
K823866 · KLR
Syva Co.
Chemistry · 20d
Cleared Jan 09, 1983
BUN-UN CENTRIFICHUM 500, #65080/81
K823300 · CDQ
Emd Chemicals, Inc.
Chemistry · 65d
Cleared Jan 09, 1983
IL 943 FLAME PHOTOMETER
K823480 · JJO
Instrumentation Laboratory CO
Chemistry · 47d
Cleared Jan 09, 1983
NO-GAUZE LAPAROTOMY SPONGE
K823671 · GDY
Surgilite Intl., Inc.
General & Plastic Surgery · 33d
Cleared Jan 09, 1983
LITE GUARD
K823673
Devon Industries, Inc.
General & Plastic Surgery · 33d
Cleared Jan 09, 1983
DISC NEEDLE SET #TX-8220
K823676 · EMI
Today'S Machining & Design, Inc.
Dental · 33d
Cleared Jan 09, 1983
FLOW-PAC LDH REAGENT SET
K823721 · CFJ
Amresco, Inc.
Chemistry · 30d
Cleared Jan 09, 1983
API MDS*
K823785 · JQP
Analytical Products, Inc.
Chemistry · 24d
Cleared Jan 09, 1983
CATHETER HOLDER
K823818 · KOD
Danek Medical, Inc.
Gastroenterology & Urology · 23d
Cleared Jan 09, 1983
ORTHODAPTIC* BONDING ADHESIVE
K823851 · DYH
Johnson & Johnson Professionals, Inc.
Dental · 18d
Cleared Jan 09, 1983
3M FRASCIA STAPLING SYSTEM
K823888 · GEF
3M Company
General & Plastic Surgery · 13d
Cleared Jan 09, 1983
EAGLE STERISET
K823902 · FRG
American Sterilizer Co.
General Hospital · 10d
Cleared Jan 09, 1983
MODEL SSE4 ELECTROSURGICAL GENERATOR
K823924 · GEI
Valleylab, Inc.
General & Plastic Surgery · 12d
Cleared Jan 09, 1983
Q-CHECK REAGENT STANDARDS
K830134 · LJG
Lab Ability, Inc.
Immunology
Cleared Jan 08, 1983
CPI PRINTER
K822857 · KAG
Cardiac Pacemakers, Inc.
General & Plastic Surgery · 103d
Cleared Jan 08, 1983
PROGRAMALITH PROGRAMMER
K823242 · KNG
Pacesetter Systems
Obstetrics & Gynecology · 68d