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
159913–159936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1982
TOTAL PROTEIN STANDARD, #65074
K822475 · JIT
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
PHOSPHOROUS STANDARD #65073
K822476 · JIS
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
ALBUMIN STANDARD, #65070
K822478 · JIT
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
BILIRUBIN CALIBRATOR #65071
K822479 · JIT
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
DEFLECTING CYTOLOGY BRUSH
K822490 · GEE
Van-Tec, Inc.
General & Plastic Surgery · 27d
Cleared Sep 14, 1982
DISPOSABLE TRANSDUCER & ACCESSORIES
K822507 · DRS
Gould, Inc.
Cardiovascular · 26d
Cleared Sep 14, 1982
YERSINIA SELECTIVE SUPPLEMENT
K822511 · JSK
Gibco Laboratories Life Technologies,...
Microbiology · 25d
Cleared Sep 14, 1982
B-HCG RADIOIMMUNOASSAY KIT
K822515 · JHI
Bioclinical Group
Chemistry · 25d
Cleared Sep 14, 1982
SINGLE CHANNEL NONFADE OSCILLOSCOPE
K822517 · DXJ
Quinton, Inc.
Cardiovascular · 25d
Cleared Sep 14, 1982
MULTIPLE, ENT CHAIR #418
K822530 · ETF
Midmark Corp.
Ear, Nose, Throat · 22d
Cleared Sep 14, 1982
NY FERMENTATION MEDIA
K822552 · JTY
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared Sep 14, 1982
CEMENT EXTRACTION INSTRUMENTATION
K822554
Surgi-Quip Inc.U
General & Plastic Surgery · 21d
Cleared Sep 14, 1982
LSM AGAR
K822558 · JWX
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared Sep 14, 1982
SXT BLOOD AGAR
K822559 · JSJ
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared Sep 14, 1982
MICROSCOPE
K822561 · EPT
Treace Medical, Inc.
General & Plastic Surgery · 21d
Cleared Sep 14, 1982
OPHTHALMIC MICROSCOPE
K822563 · HRM
Treace Medical, Inc.
General & Plastic Surgery · 21d
Cleared Sep 14, 1982
WATER BATH
K822564 · JTQ
Boekel Industries, Inc.
Microbiology · 21d
Cleared Sep 14, 1982
AURAL REFLEX INDICATOR
K822566 · ETY
Kelleher Corp.
Ear, Nose, Throat · 21d
Cleared Sep 14, 1982
EAR PROBES
K822568 · EKL
Kelleher Corp.
Dental · 21d
Cleared Sep 14, 1982
PERMA-SET INFUSION SET
K822603 · LDR
Cosmetic Sciences, Inc.
General Hospital · 18d
Cleared Sep 14, 1982
PRECAPSULED DENTAL AMALGAM
K822610 · DZS
Syntex Dental Products, Inc.
Dental · 15d
Cleared Sep 14, 1982
BEHIND-THE-EAR MODEL 115PPPCW
K822619 · ESD
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 14, 1982
ELBOW PROSTHESIS
K822632 · IRE
Hosmer Dorrance Corp.
Physical Medicine · 14d
Cleared Sep 14, 1982
CLASS II DEVICE FOR I.C.P. MONITORING
K822636 · GWM
Philadelphia Medical Specialties
Neurology · 14d