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
153865–153888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1984
OHIO UNITROL II ANESTHESIA GAS MACHINE
K840356 · BSZ
Ohio Medical Products
Anesthesiology · 85d
Cleared Apr 20, 1984
HEMOCATH
K840415 · FIQ
Quinton, Inc.
Gastroenterology & Urology · 80d
Cleared Apr 20, 1984
B2-MICRO CONTROL
K840601 · JZG
Pharmacia, Inc.
Chemistry · 70d
Cleared Apr 20, 1984
DSL-150
K840611 · IYO
Shimadzu Corp.
Radiology · 67d
Cleared Apr 20, 1984
CENTRY 2000 DIALYSIS CONTROL UNIT
K840680 · KDI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 65d
Cleared Apr 20, 1984
LCD DIGITAL THERMOMETER
K840696 · FLL
Ltd Commodities, Inc.
General Hospital · 64d
Cleared Apr 20, 1984
TENDER LIFTING CARE
K840796 · FRZ
Lancer Assoc.
General Hospital · 57d
Cleared Apr 20, 1984
TOPS DISPOS. INFUSION SET/HEMODIALYSIS
K841119 · KNZ
Top Surgical Manufacturers Co.
Gastroenterology & Urology · 36d
Cleared Apr 20, 1984
DIALYSIS TRAY
K841124 · KOC
Medcare Products
Gastroenterology & Urology · 36d
Cleared Apr 20, 1984
NCS RA LATEX TEST
K841146 · DHR
Ncs Diagnostics, Inc.
Immunology · 35d
Cleared Apr 20, 1984
RIM-BILE ESCULIN TEST
K841262 · JTO
Austin Biological Laboratories
Microbiology · 25d
Cleared Apr 20, 1984
RIM - NITRATE TEST
K841270 · JTO
Austin Biological Laboratories
Microbiology · 24d
Cleared Apr 20, 1984
RIM-HIPPURATE
K841277 · JTO
Austin Biological Laboratories
Microbiology · 23d
Cleared Apr 20, 1984
RIM 6.5% NACL
K841508 · JTO
Austin Biological Laboratories
Microbiology · 9d
Cleared Apr 19, 1984
DIGITAL SPHYGMOMANOMETER UA-231
K832721 · DXN
Copal, Inc.
Cardiovascular · 251d
Cleared Apr 19, 1984
ANTI-NATIVE DNA ANTIBODY
K834349 · KTL
Sigma Chemical Co.
Immunology · 128d
Cleared Apr 19, 1984
DADE HEMATOLOGY CALIBRATOR PLUS
K840010 · KRZ
American Dade
Hematology · 106d
Cleared Apr 19, 1984
RAPID IMMUNO-ASSAY SYS
K840257 · LLG
Applied Polytechnology, Inc.
Chemistry · 87d
Cleared Apr 19, 1984
PHASE II HCG KIT
K840328 · JHI
Medical & Scientific Designs, Inc.
Chemistry · 85d
Cleared Apr 19, 1984
ARTERIAL FILTER PURGE LINE W/CHECK VALV
K840603 · DTL
Shiley, Inc.
Cardiovascular · 69d
Cleared Apr 19, 1984
PLUS URINE HCG ASSAY
K840738 · JHJ
Monoclonal Antibodies, Inc.
Chemistry · 58d
Cleared Apr 19, 1984
KYOTEST UGK
K840829 · JIL
Kyoto Diagnostics, Inc.
Hematology · 55d
Cleared Apr 19, 1984
HIGH SPEED DISPENSER
K840938 · JQW
Micromedic Systems
Chemistry · 45d
Cleared Apr 19, 1984
LIQUID CHROMATOGRAPHIC DETECTOR LC-95
K840977 · KZR
The Perkin-Elmer Corp.
Toxicology · 44d