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
158137–158160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1983
FLORET NASAL TAMPON
K830263 · LYA
Ritmed, Inc.
General & Plastic Surgery · 58d
Cleared Mar 24, 1983
MEDILOG 9000 SYSTEM
K830295 · GWQ
Oxford Medilog, Inc.
Neurology · 56d
Cleared Mar 24, 1983
UNIFLEX
K830316 · BXB
Buckman Consultants
Physical Medicine · 52d
Cleared Mar 24, 1983
DOSIMETRIC RELEASE OF RADIATION DEV
K830327 · DTZ
American Bentley
Cardiovascular · 51d
Cleared Mar 24, 1983
BACTEC 170 TRYPTIC SOY BROTH W/RESINS
K830363 · LJF
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Mar 24, 1983
STERILE, DISPOSABLE, HYPODERMIC NEEDLES
K830378 · GAA
Abco Dealers, Inc.
General & Plastic Surgery · 48d
Cleared Mar 24, 1983
STERILE SAFETY PINS
K830381 · GAZ
Devon Industries, Inc.
General Hospital · 48d
Cleared Mar 24, 1983
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
K830390 · DXY
Telectronics, Inc.
Cardiovascular · 42d
Cleared Mar 24, 1983
ECLIPSE
K830407 · DSI
Diagnostic Medical Instruments
Cardiovascular · 45d
Cleared Mar 24, 1983
TITANALOY SUBMERSIBLE IMPLANT SYSTEM
K830414 · DZE
Boehringer/Miter, Inc.
Dental · 44d
Cleared Mar 24, 1983
RESPI-NEB-AEROSOL SYSTEM
K830417 · BTI
Professional Medical Supply, Inc.
Anesthesiology · 44d
Cleared Mar 24, 1983
CENTRAL STATION 590
K830432 · DRT
Kone Instruments, Inc.
Cardiovascular · 43d
Cleared Mar 24, 1983
PATIENT MONITOR 575
K830433 · DRT
Kone Instruments, Inc.
Cardiovascular · 43d
Cleared Mar 24, 1983
OXYGEN MONITOR OHIO 5100
K830446 · CCL
Airco/Ohio Medical Products
Anesthesiology · 42d
Cleared Mar 24, 1983
KINETIC CREATININE
K830447 · CGX
American Monitor Corp.
Chemistry · 42d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
K830460 · DOE
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
K830461 · KXS
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOUMMUNOASSAY--URINE
K830462 · DOE
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
BILIRUBIN STANDARD-LYOPHILIZED
K830469 · JIT
Dow Instruments & Reagents, Inc.
Chemistry · 37d
Cleared Mar 24, 1983
ANESTHESIA BREATHING CIRCUITS
K830470 · CAI
Mon-A-Therm, Inc.
Anesthesiology · 37d
Cleared Mar 24, 1983
KELLY-WICK TANNELER
K830471 · DWS
Intl. Medical Prosthetics Research
Cardiovascular · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY-COCAINE META
K830480 · KLN
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE
K830481 · LCL
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
K830482 · DJP
Hoffmann-La Roche, Inc.
Toxicology · 37d