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

Filters: Cleared only ×
176,076 results
173233–173256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1977
SPECTROPHOTOMETER ANALYSIS SYSTEM
K771637 · JJQ
Varian Assoc., Inc.
Chemistry · 60d
Cleared Oct 25, 1977
CHOLAR PRODU&T #17010
K771731 · CHH
Hi Chem, Inc.
Chemistry · 41d
Cleared Oct 25, 1977
9-WAY URINE TEST WITH ASCORBIC
K771755 · JIL
Miles Laboratories, Inc.
Chemistry · 39d
Cleared Oct 25, 1977
SERALUTE TSH (RIA)
K771767 · JLW
Miles Laboratories, Inc.
Chemistry · 36d
Cleared Oct 25, 1977
PONCEAU S CONCENTRATE
K771777 · HZO
Sigma Chemical Co.
Chemistry · 35d
Cleared Oct 25, 1977
ACA TRIGLYCERIDE CALIBRATOR
K771797 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
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