Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
162337–162360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1981
CASTLE #3241 GAS AERATOR
K813201 · FLI
Sybron Corp.
General Hospital · 48d
Cleared Dec 31, 1981
THERMALOG S STEAM STERILIZATION INTEGRA
K813202 · JOJ
Bio-Medical Sciences, Inc.
General Hospital · 48d
Cleared Dec 31, 1981
K51,K52 ENVIRONMENT ENCLOSURE
K813207 · LEJ
Kohler
Radiology · 43d
Cleared Dec 31, 1981
K60 HABITAT ENVIRONMENT ENCLOSURE
K813208 · LEJ
Kohler
Radiology · 43d
Cleared Dec 31, 1981
INTRAOSSEOUS DENTAL IMPLANT
K813227 · DZE
Pacific Implant, Inc.
Dental · 51d
Cleared Dec 31, 1981
CERAL-BASE METAL ALLOY
K813243 · EJH
Sillard Products, Inc.
Dental · 43d
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