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
153145–153168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1984
UREA NITROGEN REAGENT SET
K840064 · CDQ
Sterling Biochemical, Inc.
Chemistry · 157d
Cleared Jun 14, 1984
ALLO-TYPE HUMAN IMMUNOGLOBULIN-
K841114 · DGX
Genetic Testing Institute
Immunology · 91d
Cleared Jun 14, 1984
MONTGOMERY TRACHEAL T-TUBE
K841266 · BTO
E. Benson Hood Laboratories, Inc.
Anesthesiology · 80d
Cleared Jun 14, 1984
DIGITAL SPHYGMOMANOMETER UA-254
K841380 · DXN
Promedical Industries, Inc.
Cardiovascular · 73d
Cleared Jun 14, 1984
DIGITAL SPHYGMOMANOMETER UA-273
K841381 · DXN
Promedical Industries, Inc.
Cardiovascular · 73d
Cleared Jun 14, 1984
RIANEN CYCLIC-AMP RADIOIMMUNOASSAY
K841478 · CHO
New England Nuclear
Chemistry · 66d
Cleared Jun 14, 1984
FOSTER 757 SCAVENGER
K841507 · CBN
Colson Equipment, Inc.
Anesthesiology · 64d
Cleared Jun 14, 1984
BLOOD GAS CONTROL, LEVEL I(ACIDOSIS
K841783 · JJS
Bionostics, Inc.
Chemistry · 45d
Cleared Jun 14, 1984
VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY
K841890 · KZR
Varian Assoc., Inc.
Toxicology · 38d
Cleared Jun 14, 1984
FRASER HARLAKE EMERG. CARE SUCTION SYS
K841903 · BTA
Fraser Harlake, Inc.
General & Plastic Surgery · 38d
Cleared Jun 14, 1984
SIGMS PROCED. 228 UV LACTATE DEHYDRO
K841917 · CFJ
Sigma Diagnostics, Inc.
Chemistry · 36d
Cleared Jun 14, 1984
SIGMA PROCED. 245 ALKALINE PHOSPHATASE
K841918 · CJE
Sigma Diagnostics, Inc.
Chemistry · 36d
Cleared Jun 14, 1984
MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN
K842342
Med-West, Inc.
Gastroenterology & Urology
Cleared Jun 13, 1984
ORTHO* SERUM ELISA TEST SYSTEM
K833636 · DAK
Ortho Diagnostic Systems, Inc.
Immunology · 240d
Cleared Jun 13, 1984
SILVERTORQUE CARDIAC CATHETERS
K840763 · DQO
Surgimed Corp.
Cardiovascular · 111d
Cleared Jun 13, 1984
CRAFTMATIC ELECTRIC ADJUSTABLE BED
K840787 · LLI
Contour, Inc.
General Hospital · 145d
Cleared Jun 13, 1984
CENTRAL VENOUS ACCESS CATHETER CVAC-XX
K841587 · DQY
Gish Biomedical, Inc.
Cardiovascular · 107d
Cleared Jun 13, 1984
IMMU-TEC
K841862 · DCK
Medilab Corp.
Immunology · 40d
Cleared Jun 13, 1984
MONO-TEC
K841863 · KTN
Medilab Corp.
Immunology · 40d
Cleared Jun 11, 1984
CARDIOSEARCH RIGHT ATRIAL CATH-
K833873 · DQY
Cardio Search, Inc.
Cardiovascular · 216d
Cleared Jun 11, 1984
HEPARINOMETER
K834024 · KFF
Western Laboratories Corp.
Chemistry · 202d
Cleared Jun 11, 1984
ANGIOSCOPY CATHETER
K834547 · LYK
American Edwards Laboratories
Cardiovascular · 167d
Cleared Jun 11, 1984
SUCTION DEVICE-PHARYNEAL DEVICE
K840669 · JOL
Lipsky-Dale Medical Products
General Hospital · 132d
Cleared Jun 11, 1984
SILVERTORQUE VISCERAL CATHETER
K840761 · DQY
Surgimed Corp.
Cardiovascular · 109d