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
168769–168792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1979
STERILE, DISPOSABLE CENTRIFUGE BOWL
K791106 · GKT
Travenol Laboratories, S.A.
Hematology · 58d
Cleared Aug 10, 1979
SCI-PHARM ORTHODONTIC ADHESIVE
K791132 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 53d
Cleared Aug 10, 1979
BILIRUBIN CALIBRATOR CONTROL
K791141 · JJX
Beckman Instruments, Inc.
Chemistry · 53d
Cleared Aug 10, 1979
ANALYZER, SODIUM/POTASSIUM
K791175 · CEM
Nova Biomedical Corp.
Chemistry · 46d
Cleared Aug 10, 1979
DISPIRO
K791177 · BZG
Utah Medical Products, Inc.
Anesthesiology · 46d
Cleared Aug 10, 1979
CENTRIFICHEM SYSTEM 500
K791180 · JJG
Union Carbide Corp.
Chemistry · 46d
Cleared Aug 10, 1979
PRE-DENT
K791200 · GIM
Fichte, Graves, and Hunt
Chemistry · 43d
Cleared Aug 10, 1979
MODEL SE-1 EYEGLASS HEARING AID
K791203 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Aug 10, 1979
VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG
K791212 · HQE
Precision Medical Instruments, Inc.
Ophthalmic · 38d
Cleared Aug 10, 1979
GLUCOSE (GDH) REAGENT
K791213 · LFR
Gilford Diagnostics
Chemistry · 39d
Cleared Aug 10, 1979
MALIBU LABS MODEL 800 FINGER TIP CONT
K791224 · GEI
Malibu Laboratories
General & Plastic Surgery · 39d
Cleared Aug 10, 1979
BJORK-SHILEY AORTIC GRAFT VALVE PROSTH
K791225 · DXY
Shiley, Inc.
Cardiovascular · 38d
Cleared Aug 10, 1979
BAYLOR VISUAL FIELDS PROGRAMMER
K791295 · HPT
Schiff Harding Waite
Ophthalmic · 31d
Cleared Aug 10, 1979
PRISMA
K791297 · JJE
Lkb Instruments, Inc.
Chemistry · 25d
Cleared Aug 10, 1979
BOWLES STETHOSCOPE
K791333 · DQD
Amdia Medical Products
Cardiovascular · 21d
Cleared Aug 10, 1979
MULTISCOPE
K791334 · DQD
Amdia Medical Products
Cardiovascular · 21d
Cleared Aug 10, 1979
NURSESCOPE
K791335 · DQD
Amdia Medical Products
Cardiovascular · 21d
Cleared Aug 10, 1979
DUAL HEAD STETHOSCOPE
K791338 · DQD
Amdia Medical Products
Cardiovascular · 21d
Cleared Aug 10, 1979
VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT
K791355 · DPO
Ventrex Laboratories, Inc.
Toxicology · 20d
Cleared Aug 10, 1979
CAM-10 CHEST SHELL
K791406 · BYT
Lifecare Services, Inc.
Anesthesiology · 10d
Cleared Aug 10, 1979
MAINSTREAM ELEVATING WHEEL CHAIR
K791408 · ITI
Summit Services, Inc.
Physical Medicine · 15d
Cleared Aug 10, 1979
TOILET TRAINER FOR HANDICAPPED CHILD
K791423 · ILS
Kaye Products, Inc.
Physical Medicine · 10d
Cleared Aug 07, 1979
HEMODIALYZERS RP-510 AND RP-514
K791448 · FJG
Hospal Medical Corp.
Gastroenterology & Urology · 1d
Cleared Aug 03, 1979
NON-RETENTION ENEMA SYSTEM
K781923 · KPL
Hudson Kendale Assoc., Inc.
Gastroenterology & Urology · 260d