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.

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

Filters: Cleared only ×
175,230 results
157969–157992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 08, 1983
COMMUNITRACH TUBE
K823291 · BTO
Implant Technology, Inc.
Anesthesiology · 64d
Cleared Jan 08, 1983
TENS MAX
K823388 · GFK
Fujisawa Electronics Co.
Hematology · 54d
Cleared Jan 08, 1983
ELECTRODE LEAD OF SILICONE ELASTOMETER
K823452 · DTB
Telectronics, Inc.
Cardiovascular · 52d
Cleared Jan 08, 1983
ERG-JET ELECTRODE
K823767 · HLF
Life-Tech Intl., Inc.
Ophthalmic · 25d
Cleared Jan 08, 1983
CLIRANS TE08 HOLLOW FIBER DIALYZER
K823768 · HRN
Terumo Medical Corp.
Ophthalmic · 25d
Cleared Jan 07, 1983
RAPID BACTERIURIA SCREENING TEST
K820126 · JXA
Analytical Luminescence Laboratory, Inc.
Microbiology · 354d