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

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176,076 results
160249–160272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1982
IMPROVED GONO GEN
K821362 · LIC
New Horizons Diagnostics Co.
Microbiology · 89d
Cleared Aug 03, 1982
BIOBRANE R II BRAND
K820620 · FRO
Woodroof Mfg., Inc.
General & Plastic Surgery · 148d
Cleared Aug 03, 1982
CRITIKON #817 ESOPHAGEAL MULTI-PROBE
K821890 · BZT
Critikon Company, LLC
Anesthesiology · 39d
Cleared Aug 03, 1982
STARKEY MODEL HAL-1
K821908 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 36d
Cleared Aug 03, 1982
MENTOR POTENTIAL ACUITY METER
K821932 · HOX
Mentor O & O, Inc.
Ophthalmic · 35d
Cleared Aug 03, 1982
CHLAMYDELISA TEST KIT
K821967 · LJC
M.A. Bioproducts
Microbiology · 32d
Cleared Aug 03, 1982
DISPOSABLE LINEAR STAPLER-(LSR)
K821994 · GDW
Ethicon, Inc.
General & Plastic Surgery · 27d
Cleared Aug 03, 1982
JACKSON BITE BLOCKS
K822018 · JXL
Kelleher Corp.
Neurology · 26d
Cleared Aug 03, 1982
IMMUNO DIAGNOSTICS ASSAY
K822026 · CZP
Helena Laboratories
Chemistry · 22d
Cleared Aug 03, 1982
VOLU-SOL GILLS EA
K822035 · HZJ
Volu Sol Medical Industries
Pathology · 22d
Cleared Aug 03, 1982
VOLU-SOL DECALCIFER
K822036 · KDX
Volu Sol Medical Industries
Pathology · 22d
Cleared Aug 03, 1982
VOLU-SOL TAP WATER SUBSTITUTE
K822037 · PPM
Volu Sol Medical Industries
Pathology · 22d
Cleared Aug 03, 1982
VOLU-SOL ORANGE G-6(GILLS-MOD
K822038 · HZH
Volu Sol Medical Industries
Pathology · 22d
Cleared Aug 03, 1982
ACCESSORY MEDIA FOR FLOW TITERTEK MIC
K822119 · JTZ
Flow Laboratories, Inc.
Microbiology · 15d
Cleared Aug 03, 1982
DERMATOPHYTE TEST MEDIUM
K822131 · JSD
Granite Diagnostics, Inc.
Microbiology · 15d
Cleared Aug 03, 1982
IGE/THE OPHYLLINE CONTROL SERUM I,II,III
K822133 · JJY
Kallestad Laboratories, Inc.
Chemistry · 14d
Cleared Aug 03, 1982
SHIELY DUEL LUMEN SUBCLAVIAN CANNULA
K822134 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 03, 1982
PHADEBAS RAST TEST
K822141 · DHB
Pharmacia, Inc.
Immunology · 14d
Cleared Aug 02, 1982
NEUMOVENT 980
K821792 · CBK
Ultramar Marketing Corp.
Anesthesiology · 46d
Cleared Jul 30, 1982
HASSON BUEC-3
K820672 · HDP
Bivona Medical Technologies
Obstetrics & Gynecology · 141d
Cleared Jul 30, 1982
IVEX-HP PEDIATRIC EXTENSION SET-SL
K821013 · FPB
Abbott Laboratories
General Hospital · 109d
Cleared Jul 30, 1982
ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS
K821249 · GRE
Electro-Nucleonics Laboratories, Inc.
Microbiology · 91d
Cleared Jul 30, 1982
EKG (ECG) ELECTRODES
K821434 · DRX
Dupaco, Inc.
Cardiovascular · 79d
Cleared Jul 30, 1982
ARGYLE FERGUSON LEFT ATRIAL VENT CATH
K821445 · DWF
Sherwood Medical Co.
Cardiovascular · 77d