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
151993–152016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1984
ORTHO BRAND HOME PREGNANCY TEST
K842265 · LCX
Advanced Care Products
Chemistry · 40d
Cleared Jul 17, 1984
EEG 130
K842288 · HCC
Calnor of EL Paseo, Inc.
Neurology · 71d
Cleared Jul 17, 1984
VH820 HUMIDIFIER
K842340 · BTT
Bear Medical Systems, Inc.
Anesthesiology · 33d
Cleared Jul 17, 1984
TEMPERATURE 132
K842353 · HCC
Calnor of EL Paseo, Inc.
Neurology · 71d
Cleared Jul 17, 1984
EMG MODEL 133
K842354 · HCC
Calnor of EL Paseo, Inc.
Neurology · 71d
Cleared Jul 16, 1984
MINI-DOPPLER ES-100
K840542 · JOP
Hayashi Denki Co., Ltd.
Cardiovascular · 159d
Cleared Jul 16, 1984
RELAX STRESS REDUCTION SYS
K841128 · HCC
Synapse Software Corp.
Neurology · 122d
Cleared Jul 16, 1984
ADAPTOR HR-3000 REUSE
K841153 · LIF
Colorado Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Jul 16, 1984
BANANA CUFF
K841558 · KCY
Aspen Laboratories, Inc.
General & Plastic Surgery · 91d
Cleared Jul 16, 1984
BRIMFIELD FIBEROPTIC LIGHT SCOURCE
K841731 · EQH
Brimfield Scientific Instruments
Ear, Nose, Throat · 81d
Cleared Jul 16, 1984
RADCAL MODEL 4046 RADIONUCLIDE CALIBR
K841785 · KPT
Radcal Corp.
Radiology · 77d
Cleared Jul 16, 1984
RADCAL MODEL 4051 RADIONUCLIDE CALIBRA
K841786 · KPT
Radcal Corp.
Radiology · 77d
Cleared Jul 16, 1984
RADCAL MODEL 4050 RADIONUCLIDE CALIB
K841787 · KPT
Radcal Corp.
Radiology · 77d
Cleared Jul 16, 1984
MAXICAMERA 400T W/BODY CONTOUR TOMOGRA
K841996 · JAM
General Electric Co.
Radiology · 61d
Cleared Jul 16, 1984
CITOJECT CARTRIDGE SYRINGE
K842006 · EJI
Miles Laboratories, Inc.
Dental · 60d
Cleared Jul 16, 1984
ATAGO URINE SPECIFIC GRAVITY & SERUM
K842168 · JRE
Kyoto Diagnostics, Inc.
Chemistry · 46d
Cleared Jul 16, 1984
SUNMASTER
K842276 · IOB
Mt. Hood Mfr., Inc.
Physical Medicine · 38d
Cleared Jul 13, 1984
DISPOSA-SPEC
K840593 · ERA
Plasti-Products, Inc.
Ear, Nose, Throat · 155d
Cleared Jul 13, 1984
RIGHT ATRIAL CATHETER
K840742 · LJS
The Healthcare Group Laboratories, Inc.
General Hospital · 161d
Cleared Jul 13, 1984
SILVERTORQUE CEREBRAL CATHETER
K840762 · DQY
Surgimed Corp.
Cardiovascular · 141d
Cleared Jul 13, 1984
CONVENTIONAL PLASTIC DENTAL TRAYS
K841491 · EHY
Buffalo Dental Mfg. Co., Inc.
Dental · 94d
Cleared Jul 13, 1984
WEDGE PRESSURE CATHETER FLOW DIRECTED
K841705 · DYG
Mansfield Scientific, Inc.
Cardiovascular · 81d
Cleared Jul 13, 1984
CENTRAL VENOUS CATHETER W/BIG-GARD
K841828 · DQY
Norton Performance Plastics Corp.
Cardiovascular · 71d
Cleared Jul 13, 1984
KIDD VAGINAL SPECULUM
K841867 · HIB
Paul H. Schneider Ent.
Obstetrics & Gynecology · 70d