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

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175,820 results
143905–143928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1986
GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM
K860782 · LQF
Gen-Probe, Inc.
Microbiology · 121d
Cleared Jul 02, 1986
DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS
K860867 · DQO
Medical Components, Inc.
Cardiovascular · 117d
Cleared Jul 02, 1986
RAMP PROGESTURINE PDG ASSAY--48 TEST KIT
K860924 · JLS
Monoclonal Antibodies, Inc.
Chemistry · 113d
Cleared Jul 02, 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED
K860999 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 106d
Cleared Jul 02, 1986
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
K861303 · CGA
Miles Laboratories, Inc.
Chemistry · 86d
Cleared Jul 02, 1986
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
K861778 · JQP
Miles Laboratories, Inc.
Chemistry · 55d
Cleared Jul 02, 1986
V-TREND EIA TSH
K861918 · JLW
V-Tech, Inc.
Chemistry · 44d
Cleared Jul 02, 1986
HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY
K862083 · JHJ
Hygeia Sciences
Chemistry · 30d
Cleared Jul 02, 1986
MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD
K862276 · DTB
Intermedics, Inc.
Cardiovascular · 16d
Cleared Jul 02, 1986
SINGLE-USE PATIENT UNDERPAD
K862348 · KME
Procter & Gamble Mfg. Co.
General Hospital · 12d
Cleared Jul 02, 1986
MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM
K862425 · JSI
Gibco Laboratories Life Technologies,...
Microbiology · 6d
Cleared Jul 01, 1986
ELEFIX ELECTRODE CREAM
K860210 · GYB
Nihon Kohden America, Inc.
Neurology · 160d
Cleared Jul 01, 1986
PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP
K860634 · DXN
Panasonic Co. Div. Matsu Elec. Corp....
Cardiovascular · 131d
Cleared Jul 01, 1986
CEPHALOSTAT
K860835 · EHD
Dallas Dental Co.
Radiology · 118d
Cleared Jul 01, 1986
S&W TYPE 888 ELECTRODE
K861158 · DRX
National Medical Technology
Cardiovascular · 95d
Cleared Jul 01, 1986
ROTAVIRUS LATEX AGGLUTINATION ASSAY
K861172 · LIQ
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 95d
Cleared Jul 01, 1986
CHOLESTEROL CALIBRATORS
K861314 · JIT
Sigma Diagnostics, Inc.
Chemistry · 84d
Cleared Jul 01, 1986
NON-ADHERING DRESSING WITH POVIDONE-IODINE
K861384 · FRO
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 78d
Cleared Jul 01, 1986
CAVAFIX, CENTRAL VENOUS CATHETER KIT
K861479 · FOZ
Burron Medical Products, Inc.
General Hospital · 70d
Cleared Jul 01, 1986
CREATININE PROCEDURE
K861655 · CGX
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
INORGANIC PHOSPHORUS PROCEDURE
K861661 · CEO
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
AMYLASE PROCEDURE
K861664 · CIJ
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
BLOOD UREA NITROGEN (BUN) PROCEDURE
K861666 · CDQ
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
TRIGLYCERIDE (TRINDER) PROCEDURE
K861670 · CDT
Data Medical Associates, Inc.
Chemistry · 62d