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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
148153–148176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1985
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
K852473 · JGS
Roche Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Jul 12, 1985
CELLGRO WILLIAMS' MEDIUM E
K852475 · KIT
Mediatech, Inc.
Pathology · 31d
Cleared Jul 12, 1985
SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
K852483 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Jul 12, 1985
CELLGRO(ISCOVE'S MEDIUM) MODIFICATION
K852485 · KIT
Mediatech, Inc.
Pathology · 31d
Cleared Jul 12, 1985
BIOGLAS MICROCARRIER BEAD
K852506 · KJB
Solohill Engineering, Inc.
Pathology · 30d
Cleared Jul 12, 1985
TECHNICON CHEMI
K852565 · CGX
Technicon Instruments Corp.
Chemistry · 35d
Cleared Jul 12, 1985
MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON
K852568 · KIT
Sigma Chemical Co.
Pathology · 24d
Cleared Jul 12, 1985
TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE
K852573 · KLS
Technicon Instruments Corp.
Toxicology · 24d
Cleared Jul 12, 1985
CLED AGAR
K852578 · JSH
American Laboratory Supply, Inc.
Microbiology · 24d
Cleared Jul 12, 1985
GONI-KIT
K852582 · JSX
Culture Kits, Inc.
Immunology · 24d
Cleared Jul 12, 1985
DATA CHEM IRON PROCEDURE
K852583 · CFM
Data Medical Associates, Inc.
Chemistry · 24d
Cleared Jul 12, 1985
DC-LIP, CATALOGUE NUMBER SE-020
K852594 · JJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Jul 12, 1985
DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
K852595 · JGS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Jul 12, 1985
MCCOY'S 5A MEDIUM-LIQUID FORM
K852602 · KIT
Mediatech, Inc.
Pathology · 23d
Cleared Jul 12, 1985
MCCOY'S 5A MEDIUM - POWDERED FORM
K852603
Mediatech, Inc.
Pathology · 23d
Cleared Jul 12, 1985
X-AMYLASE ASSAY KIT
K852636 · CIJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 22d
Cleared Jul 11, 1985
KENZ 80Z MARK II
K843731 · DSI
Suzuken Co., Ltd.
Cardiovascular · 290d
Cleared Jul 11, 1985
THE WHITE RIVER PORTA-ELEC-BREAST PUMP
K850705 · HGX
Natural Technologies, Inc.
Obstetrics & Gynecology · 140d
Cleared Jul 11, 1985
CONCEPT DEFRERE ELECTRODE
K851040 · GEI
Concept, Inc.
General & Plastic Surgery · 119d
Cleared Jul 11, 1985
CARDIAC COOLING JACKET
K851077 · KRI
Pat O. Daily
Cardiovascular · 115d
Cleared Jul 11, 1985
MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD
K851457 · DTD
Intermedics, Inc.
Cardiovascular · 91d
Cleared Jul 11, 1985
MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD
K851458 · DTD
Intermedics, Inc.
Cardiovascular · 91d
Cleared Jul 11, 1985
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE
K851461 · DTB
Telectronics, Inc.
Cardiovascular · 91d
Cleared Jul 11, 1985
NAMAN POTTS COURNAND NEEDLE
K851832 · DWS
Manan Manufacturing Co., Inc.
Cardiovascular · 76d