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
152665–152688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1984
OBSTETRICAL ULTRASOUND COMPUTER
K840623 · HEM
R & S Systems
Obstetrics & Gynecology · 87d
Cleared May 11, 1984
OPAQUE COATING & SURFACE STAIN
K840751 · EBD
Dentsply Intl.
Dental · 78d
Cleared May 11, 1984
ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
K840867 · DEI
Intl. Diagnostic Technology
Immunology · 74d
Cleared May 11, 1984
TDX ACETAMINOPHEN
K840941 · LDP
Abbott Laboratories
Toxicology · 67d
Cleared May 11, 1984
DYNAMIC CONDYLAR SCREW OR D.C.S.
K840954 · HRS
Synthes (Usa)
Orthopedic · 67d
Cleared May 11, 1984
SURGICAL CURETTE, VARIOUS
K841004 · HCY
Premier Dental Products Co.
Obstetrics & Gynecology · 63d
Cleared May 11, 1984
PROLACTIN RIABEAD PROLACTIN RADIOIMM
K841118 · CFT
Abbott Laboratories
Chemistry · 57d
Cleared May 11, 1984
HY-BOND ZINC OXIDE EUGENOL TEMP.
K841196 · EMA
Shofu Dental Corp.
Dental · 51d
Cleared May 11, 1984
ULTRACLONE ECL-01-800 CELL LINE
K841337 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-600 CELL LINE
K841338 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRA CLONE ECL-01-700 CELL LINE
K841339 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-900 CELL LINE
K841340 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-1000 CELL LINE
K841341 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-400 CELL LINE
K841342 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-100 CELL LINE
K841343 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-300 CELL LINE
K841344 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-500 CELL LINE
K841345 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-200 CELL LINE
K841346 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
CREATININE - A.A.S.
K841377 · CGX
Advanced Analytical Systems, Inc.
Chemistry · 38d
Cleared May 11, 1984
SODIUM & POTASSIUM STANDARD SOLUT
K841419 · JIX
Reagent Laboratory, Inc.
Chemistry · 36d
Cleared May 11, 1984
SODIUM & POTASSIUM STANDARD SOL 80
K841420 · JIX
Reagent Laboratory, Inc.
Chemistry · 36d
Cleared May 11, 1984
DAILY WASH SOLUTION 5
K841421 · JJO
Reagent Laboratory, Inc.
Chemistry · 36d
Cleared May 11, 1984
VOLUME TEST DYE 6
K841422 · JJO
Reagent Laboratory, Inc.
Chemistry · 36d
Cleared May 11, 1984
VENTRESCREEN, MULTIPLE ALLERGEN DISCS
K841516 · DHB
Ventrex Laboratories, Inc.
Immunology · 29d