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

Filters: Cleared only ×
176,076 results
173041–173064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1977
UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS
K771102 · LFR
The Dow Chemical Co.
Chemistry · 155d
Cleared Nov 22, 1977
PRESSURE MONITOR MANOMETRIC SYS.
K771265 · KLA
Physio-Control Corp.
Gastroenterology & Urology · 132d
Cleared Nov 22, 1977
LATELET RETENTION COLUMN
K771523 · JBZ
Bd Becton Dickinson Vacutainer...
Hematology · 106d
Cleared Nov 22, 1977
THROMBO-SCREEN PLATELET ADHESION
K771678 · JBZ
Bay Area Hema. Onco. Clinic. & Res. L
Hematology · 81d
Cleared Nov 22, 1977
HILL TUBE
K771723 · KLA
Physio-Control Corp.
Gastroenterology & Urology · 70d
Cleared Nov 22, 1977
EVOKED RESPONSE SYS., MODEL 10
K771742 · GWK
Grass Instrument Co.
Neurology · 68d
Cleared Nov 22, 1977
CHLORIDE
K771832 · JFS
Gamma Enterprises, Inc.
Chemistry · 62d
Cleared Nov 22, 1977
LACTATE DEHYDROGENASE
K771836 · CFJ
Gamma Enterprises, Inc.
Chemistry · 62d
Cleared Nov 22, 1977
WETTING AGENTS
K771843
Gamma Enterprises, Inc.
Chemistry · 62d
Cleared Nov 22, 1977
WALL TRANSFORMERS 74710 & 74910
K771864 · GCW
Welch Allyn, Inc.
Gastroenterology & Urology · 50d
Cleared Nov 22, 1977
TRYPSIN 1%
K771955 · IBG
Flow Laboratories, Inc.
Microbiology · 36d
Cleared Nov 22, 1977
ELECTROTHERM MODELS TC-100 & M-99
K771995 · FLL
Electromedics, Inc.
Chemistry · 32d
Cleared Nov 22, 1977
TELETHERMOMETER MODEL T T-100
K771996 · FLL
Electromedics, Inc.
Chemistry · 32d
Cleared Nov 22, 1977
ECG TELEMETRY SYSTEM
K772000 · DRG
Mennen Greatbatch Electonics
Cardiovascular · 32d
Cleared Nov 22, 1977
PHYSIOLOGICAL RECORDER MODEL 721A
K772052 · DSF
Datascope Corp.
Cardiovascular · 22d
Cleared Nov 22, 1977
PHYSIOLOGICAL RECORDER MODEL 740
K772054 · DSF
Datascope Corp.
Cardiovascular · 22d
Cleared Nov 22, 1977
PHYSIOLOGICAL MONITOR MODEL 871
K772056 · DRT
Datascope Corp.
Cardiovascular · 22d
Cleared Nov 22, 1977
IN VITRO DIAGNOSTIC REAGENT
K772096 · CDX
Pcl-Ria, Inc.
Chemistry · 15d
Cleared Nov 22, 1977
HEARTRATE METER MODEL 650, P/N 000119
K772097 · DRT
Quinton, Inc.
Cardiovascular · 15d
Cleared Nov 22, 1977
IN VITRO DIGOXIN RIA TEST
K772110 · DNL
Clinical Assays, Inc.
Immunology · 15d
Cleared Nov 22, 1977
FLUORESCEIN CONJUGATED
K772128 · DCE
Kallestad Laboratories, Inc.
Immunology · 11d
Cleared Nov 22, 1977
AMPLIFIER MODULE, 78211A ECG
K772132 · DRR
Hewlett-Packard Co.
Cardiovascular · 8d
Cleared Nov 22, 1977
LANCER BIOPSY HOLDER
K772149 · KER
Sherwood Medical Industries
Pathology · 8d
Cleared Nov 22, 1977
LIGHT-PEN SYSTEM FOR QUANTI. ANALY.
K772158 · DXG
Varian Assoc., Inc.
Cardiovascular · 6d