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
165169–165192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1980
CBC PAP TEST KIT
K802153 · JFH
Calbiochem-Behring Corp.
Chemistry · 65d
Cleared Nov 12, 1980
MODEL AS* 7B AUTOSYRINGE INFUSION PUMP
K802166 · FLN
Baxter Healthcare Corp
General Hospital · 65d
Cleared Nov 12, 1980
CARDIOSCOPE J200
K802179 · DRS
Telectronics, Inc.
Cardiovascular · 64d
Cleared Nov 12, 1980
ATGM MODEL AT-80
K802191 · DXN
Herald of America, Inc.
Cardiovascular · 63d
Cleared Nov 12, 1980
KOTEX SECURITY TUBE TAMPONS
K802193 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 63d
Cleared Nov 12, 1980
AB-TROL COAGULATION CONTROL
K802232 · GGW
Helena Laboratories
Hematology · 58d
Cleared Nov 12, 1980
VAXIOM FAMILY OF RF LESION PROBES & ELEC
K802243 · GXI
Progress Mankind Technology
Neurology · 57d
Cleared Nov 12, 1980
CBC PLT-4
K802265 · JPK
R&D Systems, Inc.
Hematology · 57d
Cleared Nov 12, 1980
PLT-4 SIZE-CHECK
K802267 · JPK
R&D Systems, Inc.
Hematology · 57d
Cleared Nov 12, 1980
HI-TEMP LOOPTIP SURGICAL CAUTERY
K802330 · GEI
Medical Products Development, Inc.
General & Plastic Surgery · 50d
Cleared Nov 12, 1980
INSTANT BRIDGE
K802333 · KLE
Scientific Pharmaceuticals, Inc.
Dental · 50d
Cleared Nov 12, 1980
12SSL ECG ANALYSIS PROG.(SCALER LEAD)
K802369 · LOS
Marquette Electronics, Inc.
Cardiovascular · 44d
Cleared Nov 12, 1980
SURGICAL FACE MASK
K802373 · FXX
Louis M. Gerson Co., Inc.
General Hospital · 44d
Cleared Nov 12, 1980
CUSTOM DRESSING TRAY/CARDINAL CUSHING
K802383 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 41d
Cleared Nov 12, 1980
CENTRAL VENOUS CATHETER DRESSING TRAY
K802384 · FPX
American Medical Disposable, Inc.
General & Plastic Surgery · 41d
Cleared Nov 12, 1980
CUSTOM DRESSING TRAY-WET TO DRY/MASS.
K802385 · FPX
American Medical Disposable, Inc.
General & Plastic Surgery · 41d
Cleared Nov 12, 1980
SUTURE WOUND TRAY MILFORD WHITTINSVILLE
K802386 · FMC
American Medical Disposable, Inc.
General Hospital · 41d
Cleared Nov 12, 1980
MINOR DRESSING TRAY-MILFORD HOSP.
K802387 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 41d
Cleared Nov 12, 1980
MAJOR DRESSING TRAY-MILFORD HOSP.
K802388 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 41d
Cleared Nov 12, 1980
AO NON-CONTACT II TONOMETER
K802419 · HKX
American Optical Corp.
Ophthalmic · 37d
Cleared Nov 12, 1980
PHADEBACT HAEMOPHILUS TEST
K802423 · GRO
Pharmacia, Inc.
Microbiology · 40d
Cleared Nov 12, 1980
SCHURING OSSICLE CUP & COLUMELLA PROSTH.
K802431 · ETB
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 37d
Cleared Nov 12, 1980
GESTE FOLLOW KIT DETERM. OF HPL
K802454 · JMF
Syn-Kit, Inc.
Immunology · 35d
Cleared Nov 12, 1980
BICARB-O-MATE HEMODIALYSIS SOD. BICARB.
K802465 · FKR
Renal Systems, Inc.
Gastroenterology & Urology · 34d