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
141721–141744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1986
VISION (TM) CALCIUM
K863670 · CIC
Abbott Laboratories
Chemistry · 56d
Cleared Nov 13, 1986
AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1
K863719 · CIJ
Technicon Instruments Corp.
Chemistry · 51d
Cleared Nov 13, 1986
IMMUNO-CEPT D (BETA-MONOCLONAL)
K863741 · JHJ
Immunostics Co., Inc.
Chemistry · 51d
Cleared Nov 13, 1986
MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT
K863756 · BZO
Nova-Ventrx
Anesthesiology · 49d
Cleared Nov 13, 1986
LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES
K863874 · CDT
Electro-Nucleonics Laboratories, Inc.
Chemistry · 41d
Cleared Nov 13, 1986
GLUCOSE OXIDASE
K863926 · CGA
Tech-Co, Inc.
Chemistry · 36d
Cleared Nov 13, 1986
TERUMO SENSIBEAD(TM) EIA HLH KIT
K863929 · CEP
Terumo Medical Corp.
Chemistry · 36d
Cleared Nov 13, 1986
A-GENT(TM) LIQUID GLUCOSE TRINDER
K863948 · CGA
Abbott Laboratories
Chemistry · 34d
Cleared Nov 13, 1986
MACULOSCOPE(TM)
K863956 · GWE
Doran Instruments, Inc.
Neurology · 34d
Cleared Nov 13, 1986
KEYNOTE
K863995 · ILQ
Sensory Aids Corp.
Physical Medicine · 30d
Cleared Nov 13, 1986
MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID
K864028 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 13, 1986
AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID
K864029 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 13, 1986
MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID
K864030 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 13, 1986
MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID
K864031 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 13, 1986
RAPID ACID FAST STAIN
K864033 · KJY
Sigma Diagnostics, Inc.
Pathology · 29d
Cleared Nov 13, 1986
KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER
K864037 · HJB
Kera Corp.
Ophthalmic · 28d
Cleared Nov 13, 1986
ORION 3001, LASER PHOTOCOAGULATOR
K864063 · HQF
G. Rodenstock Instrumente GmbH
Ophthalmic · 24d
Cleared Nov 13, 1986
PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID
K864069 · JWY
Austin Biological Laboratories
Microbiology · 24d
Cleared Nov 13, 1986
FAULKNER FORCEPS
K864071 · HNR
Staar Surgical Co.
Ophthalmic · 24d
Cleared Nov 13, 1986
UBI MAGIWEL(TM) FSH QUANTITATIVE
K864080 · CGJ
United Biotech, Inc.
Chemistry · 24d
Cleared Nov 13, 1986
MECHANICAL OXYGEN REGULATOR
K864127 · NFB
Travomed, Inc.
Anesthesiology · 23d
Cleared Nov 13, 1986
OPTI-BRUSH
K864157 · LPN
Willmar Contact Lens Clinic
Ophthalmic · 21d
Cleared Nov 13, 1986
HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS
K864172 · FNL
Hill-Rom, Inc.
General Hospital · 20d
Cleared Nov 13, 1986
HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT)
K864186 · FNL
Hill-Rom, Inc.
General Hospital · 17d