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
164377–164400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1981
AIRCAST TENNIS ARM BAND
K810288 · IQI
Aircast, Inc.
Physical Medicine · 10d
Cleared Feb 12, 1981
OHIO CAL-CHEK
K810290 · BXW
Ohio Medical Products
Anesthesiology · 9d
Cleared Feb 10, 1981
METRONIDAZOLE DISCS
K801805 · JWY
G.D. Searle and Co.
Microbiology · 196d
Cleared Feb 10, 1981
EXETER TOTAL HIP SYSTEM
K803126 · JDI
Howmedica Corp.
Orthopedic · 60d
Cleared Feb 10, 1981
HOWMEDICA KNEE BRUSH
K803127 · LXH
Howmedica Corp.
Orthopedic · 60d
Cleared Feb 10, 1981
HALOGEN HEADLIGHT SYSTEM
K810117 · EBA
Colmed, Ltd.
Dental · 25d
Cleared Feb 10, 1981
MODEL AM 721 ELECTROLYTE ANALYZER
K810135 · JGS
Abbott Diagnostics
Chemistry · 20d
Cleared Feb 10, 1981
MOI-STIR
K810157 · LFD
Kingswood Laboratories, Inc.
Dental · 20d
Cleared Feb 10, 1981
MODEL AM 722
K810203 · JFP
Applied Medical Technologies
Chemistry · 18d
Cleared Feb 10, 1981
MAGIC-TOUCH
K810210 · DYH
Sci-Pharm, Inc.
Dental · 15d
Cleared Feb 10, 1981
T3 RIA KIT
K810211 · CDP
E. R. Squibb & Sons, Inc.
Toxicology · 15d
Cleared Feb 10, 1981
DAC-CEL T3 UPTAKE
K810212 · KHQ
Burroughs Wellcome Co.
Chemistry · 14d
Cleared Feb 10, 1981
DAC-CEL TSH
K810213 · JLW
Burroughs Wellcome Co.
Chemistry · 14d
Cleared Feb 10, 1981
ARMSTRONG SPINAL APPLIANCE
K810224 · KWP
Howmedica Corp.
Orthopedic · 14d
Cleared Feb 10, 1981
SORBOTHANE
K810228 · KNP
Hamilton Kent
Physical Medicine · 14d
Cleared Feb 10, 1981
CODE IM 2050 AMERLEX FREE T4 RIA KIT
K810231 · CEC
Amersham Corp.
Chemistry · 14d
Cleared Feb 10, 1981
LEECO P.A.P. - QUANT DIAGNOSTIC KIT
K810232 · JFH
Leeco Diagnostics, Inc.
Chemistry · 14d
Cleared Feb 10, 1981
ACETAMINOPHEN/SALICYLATE CONTROL
K810235 · DIF
Clin Tech Diagnostics Corp.
Toxicology · 13d
Cleared Feb 10, 1981
SODIUM & POTASSIUM TEST KIT
K810253 · JGM
Mallinckrodt Critical Care
Chemistry · 11d
Cleared Feb 10, 1981
EUROCHIMA UREA NITROGEN
K810261 · CDL
Volu Sol Medical Industries
Chemistry · 11d
Cleared Feb 09, 1981
POLY FLEX IMPLANTABLE PACING LEAD
K802295 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Feb 09, 1981
TEST KIT FOR DETECTION OF HERPES SIMPLEX
K802526 · LGC
Bartels & Stout, Inc.
Microbiology · 117d
Cleared Feb 09, 1981
DIRECT FLUORESCENT ANTIBODY KIT/HERPES
K802590 · GQL
Bartels & Stout, Inc.
Microbiology · 117d
Cleared Feb 09, 1981
FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM
K803196 · HSB
Howmedica Corp.
Orthopedic · 55d