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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
142657–142680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1986
COMPANION OXYGEN SAVER
K863695 · NFB
Puritan Bennett Corp.
Anesthesiology · 23d
Cleared Oct 15, 1986
SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE
K863703 · CCK
Salter Labs
Anesthesiology · 22d
Cleared Oct 15, 1986
MYOLEX
K863730 · DDR
Orion Corp.
Immunology · 22d
Cleared Oct 15, 1986
MODEL A-1 OXYGEN ANALYZER
K863806 · CCL
Medical, Inc.
Anesthesiology · 15d
Cleared Oct 15, 1986
CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE)
K863863 · DSH
Cardionostics, Inc.
Cardiovascular · 12d
Cleared Oct 14, 1986
NEUROSCOPE SEEG
K861884 · GWO
Siegen Corp.
Neurology · 152d
Cleared Oct 14, 1986
CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)
K862233 · KLI
Ciba Corning Diagnostics Corp.
Chemistry · 125d
Cleared Oct 14, 1986
MICROFILL PONTIC
K862546 · EBF
Kulzer, Inc.
Dental · 103d
Cleared Oct 14, 1986
DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000
K863089 · GDY
Lifestream Int'L, Inc.
General & Plastic Surgery · 62d
Cleared Oct 14, 1986
PEAK OVULATION PREDICTOR
K863121 · NGE
Micron Technology, Inc.
Toxicology · 61d
Cleared Oct 14, 1986
MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL
K863479 · GWM
Medical Measurements, Inc.
Neurology · 35d
Cleared Oct 14, 1986
DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE
K863482 · GCY
Cardio Metrics, Inc.
General & Plastic Surgery · 35d
Cleared Oct 14, 1986
STAND, IRRIGATOR, STEEL, FOLDING
K863690
Brenner Metal Prod Corp.
General & Plastic Surgery · 25d
Cleared Oct 14, 1986
MODEL 709 BIPOLAR MICRO COAGULATOR
K863701 · GEI
Bergen Mfg.
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K863710 · IZH
Ausonics Pty , Ltd.
Radiology · 21d
Cleared Oct 14, 1986
BANDAGE, GAUZE, TWO-PLY, VARIOUS SIZES
K863713 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZES
K863714 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
NORFOLK MEDICAL POSI-GRIP 'HUBER POINT' NEEDLE
K863721
Norfolk Medical Products, Inc.
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
INSTRUMENT STERILIZATION TRAY
K863726 · FSM
Medical Technology Development Corp.
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
TOWEL PACK, SURGICAL
K863733
East Texas Lighthouse For the Blind
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
SPONGES STERILE TWIN PAKT AND SINGLES
K863737 · EFQ
Hermitage Hospital Products, Inc.
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
PA EQUALIZER
K863787 · ESD
Electone, Inc.
Ear, Nose, Throat · 18d
Cleared Oct 14, 1986
SAWBLADE
K863788 · GFA
Tava Surgical Instruments
General & Plastic Surgery · 18d
Cleared Oct 14, 1986
JAW FIXATION ASSEMBLY
K863799 · DYX
Medical Products & Research, Inc.
Dental · 15d