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
161497–161520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1981
DENTAL FLOSS HOLDER
K813248 · JES
Sewon Industry
Dental · 42d
Cleared Dec 31, 1981
IN-STOPPER (INJECTION CAP
K813259 · FPA
Burron Medical Products, Inc.
General Hospital · 41d
Cleared Dec 31, 1981
TRACHEOSTOMY CARE TRAY
K813260 · LDQ
E.M. Adams
General & Plastic Surgery · 41d
Cleared Dec 31, 1981
EMERGENCY POWER PAC (EMPAC)
K813273 · HKP
Optical Micro Systems, Inc.
Ophthalmic · 41d
Cleared Dec 31, 1981
UVA HEX UNIT
K813307 · FTC
Sun Shanty, Inc.
General & Plastic Surgery · 38d
Cleared Dec 31, 1981
COMPRESSOR, AIR, PORTABLE
K813311 · BTI
The Biomed Group
Anesthesiology · 37d
Cleared Dec 31, 1981
UNIVERSAL SUCTION PUMP TYPE EUS
K813312 · BTA
Egnell, Inc.
General & Plastic Surgery · 37d
Cleared Dec 31, 1981
CUSTOM-IN-THE-EAR HEARING AID
K813316 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 37d
Cleared Dec 31, 1981
MODEL 6200 OXYGEN CONCENTRATOR
K813320 · CAW
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 37d
Cleared Dec 31, 1981
SEPCOR TEMPERATURE MONITOR
K813327 · KSE
Separation Science Corp.
Hematology · 37d
Cleared Dec 31, 1981
ALPHATEMP CLINICAL THERMOMETER
K813333 · FLL
Alpha Omega Engineering Corp.
General Hospital · 37d
Cleared Dec 31, 1981
POST-AURICULAR HEARING AID MODEL ASP-103
K813344 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 36d
Cleared Dec 31, 1981
NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER
K813351 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 34d
Cleared Dec 31, 1981
MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL
K813359 · GMJ
American Scientific Products
Microbiology · 31d
Cleared Dec 31, 1981
DISPOSABLE TRACH SWIVEL CONNECTOR
K813383 · BZA
Intec.
Anesthesiology · 29d
Cleared Dec 31, 1981
HEMODIALYSATE
K813388 · KPO
Edlaw Pharmaceuticals, Inc.
Hematology · 29d
Cleared Dec 31, 1981
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
K813395 · JBD
Helena Laboratories
Microbiology · 27d
Cleared Dec 31, 1981
FLO-GARD 8000 INFUSION PUMP SYSTEM
K813403 · FRN
Travenol Laboratories, S.A.
General Hospital · 24d
Cleared Dec 31, 1981
AIR MATTRESS
K813407 · FNM
Trans World Agency, Inc.
General Hospital · 24d
Cleared Dec 31, 1981
GLUCOSE ENZYME-COLOR REAGENT SET
K813412 · CGA
Diagnostic Specialties
Chemistry · 27d
Cleared Dec 31, 1981
PEAK FLOW MONITOR
K813414 · BZH
Biotrine Corp.
Anesthesiology · 24d
Cleared Dec 31, 1981
UREA NITROGEN REAGENT SET
K813415 · CDW
Anco Medical Reagents & Assoc.
Chemistry · 24d
Cleared Dec 31, 1981
ULTRACHEM GLUC-DH
K813427 · LFR
Harleco
Chemistry · 24d
Cleared Dec 31, 1981
SHUNT ADAPTER
K813428 · FKN
Quinton, Inc.
Gastroenterology & Urology · 23d