FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
172201–172224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 22, 1977
EMIT THEOPHYLLINE CONTROL
K772166 · DLJ
Syva Co.
Toxicology · 6d
Cleared Nov 22, 1977
EMIT LIDOCAINE CONTROL
K772167 · DLJ
Syva Co.
Toxicology · 6d
Cleared Nov 21, 1977
CAMERA ADAPTER FOR ENDOSCOPES
K771962 · HET
Kli
Obstetrics & Gynecology · 35d
Cleared Nov 21, 1977
HEARING AID-MODEL CE-2
K772100 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 14d
Cleared Nov 21, 1977
HEARING AID-MODEL PE-1
K772101 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 14d
Cleared Nov 21, 1977
AMPLIFIER OTRONA, MODEL N3A-EMG
K772102 · GWL
Honeywell, Inc.
Neurology · 14d