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
172393–172416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1977
ACA GLUTAMYL TRANSFERASE
K771800 · JJT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA CARBON DIOXIDE CALIBRATOR
K771801 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA IRON CALIBRATOR
K771802 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA PHOSPHORUS CALIBRATOR
K771803 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA AMMONIA CALIBRATOR
K771804 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
CENTRIFICHEM SYS 400 ANALYZER
K771813 · JJG
Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Oct 25, 1977
ALBUMIN
K771828 · CIX
Gamma Enterprises, Inc.
Chemistry · 26d
Cleared Oct 25, 1977
BLOOD UREA NITROGEN BUN
K771830 · CDW
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Oct 25, 1977
CALCIUM
K771831 · CIC
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Oct 25, 1977
TOTAL PROTEIN
K771841 · CEK
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Oct 25, 1977
URIC ACID
K771842 · CDH
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Oct 25, 1977
WASH SOLUTIONS
K771844
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Oct 25, 1977
MARTIN LEWIS AGAR (JEMBEC)
K771870 · JTY
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared Oct 25, 1977
MARTIN LEWIS AGAR (PLATE)
K771871 · JTY
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared Oct 25, 1977
MARTIN LEWIS TRANSGROW
K771872 · JTY
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared Oct 25, 1977
VISION SERIES DENTAL CHAIR
K771873 · KLC
Chayes Virginia, Inc.
Dental · 21d
Cleared Oct 25, 1977
DINAMAP MADEL 845
K771895 · DXN
Applied Medical Research
Cardiovascular · 19d
Cleared Oct 25, 1977
DINAMAP MODEL 835
K771896 · DXN
Applied Medical Research
Cardiovascular · 19d
Cleared Oct 25, 1977
DINAMAP MODEL 837
K771897 · DXN
Applied Medical Research
Cardiovascular · 19d
Cleared Oct 25, 1977
LINEAR ARRAY B-MODE SCANNER
K771934 · IYO
G.D. Searle and Co.
Radiology · 11d
Cleared Oct 25, 1977
12MM SELF-SEALING TROCAR & CANNULA
K771958 · HET
Kli
Obstetrics & Gynecology · 8d
Cleared Oct 25, 1977
8MM SELF-SEALING TROCAR & CANNULA
K771959 · HET
Kli
Obstetrics & Gynecology · 8d
Cleared Oct 25, 1977
TUBAL OCCLUSION INSERTER/LAPAROSCOPE
K771960 · HET
Kli
Obstetrics & Gynecology · 8d
Cleared Oct 25, 1977
DUAL INCISION TUBAL OCCLUS. BAND APPLI.
K771961 · HET
Kli
Obstetrics & Gynecology · 8d