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
142705–142728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 1986
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K863821 · JTZ
Gibco Laboratories Life Technologies,...
Microbiology · 9d
Cleared Oct 08, 1986
CSI/MPR OR CSI/MPR PLUS
K861852 · LLZ
Columbia Scientific, Inc.
Radiology · 147d
Cleared Oct 08, 1986
READS RF TEST KIT FOR IGM RHEUMATOID FACTOR
K863238 · DHR
Biostar Medical Products, Inc.
Immunology · 48d
Cleared Oct 08, 1986
TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY
K863345 · DBF
Hybritech, Inc.
Immunology · 40d
Cleared Oct 08, 1986
MODIFICATION OF STERILITY CYCLE PARAMETERS
K863365 · DXY
Coratomic, Inc.
Cardiovascular · 36d
Cleared Oct 08, 1986
CORDIS MULTICOR II MODEL 402D PACER
K863417 · DXY
Cordis Corp.
Cardiovascular · 35d
Cleared Oct 08, 1986
MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)
K863582 · DXY
Cook Pacemaker Corp.
Cardiovascular · 23d
Cleared Oct 08, 1986
MODIFIED GAS SAMPLING KIT
K863640 · CCK
Respiratory Support Products, Inc.
Anesthesiology · 35d
Cleared Oct 08, 1986
DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300
K863820 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 8d
Cleared Oct 07, 1986
SCREW-VENT (TM) IMPLANT/ENDOSSEOUS SCREW IMPLANT
K861426 · DZE
Core-Vent Corp.
Dental · 174d
Cleared Oct 07, 1986
CT MAX, CATALOG NO. B7940 HA
K862317 · JAK
General Electric Co.
Radiology · 111d
Cleared Oct 07, 1986
PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT
K862447 · KHQ
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 102d
Cleared Oct 07, 1986
PUNCH BIOPSY KIT
K862562 · KNW
Clinipad Corp.
Gastroenterology & Urology · 96d
Cleared Oct 07, 1986
LDS - LASER DELIVERY SYSTEM
K862568 · HQF
Coherent Medical Group
Ophthalmic · 92d
Cleared Oct 07, 1986
CAULK'S POLISHING PASTE
K863174 · EBF
Dentsply Intl.
Dental · 50d
Cleared Oct 07, 1986
DURA NEB(TM) 2000 PORTABLE COMPRESSOR
K863339 · BTI
Thera Tec, Inc.
Anesthesiology · 40d
Cleared Oct 07, 1986
CANNON NASAL SPLINT
K863382 · EPP
Treace Medical, Inc.
Ear, Nose, Throat · 34d
Cleared Oct 07, 1986
SUCTION-OFF
K863653 · HXD
B&B Medical Technologies, Inc.
General & Plastic Surgery · 19d
Cleared Oct 07, 1986
BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP
K863683 · FRN
C.R. Bard, Inc.
General Hospital · 18d
Cleared Oct 07, 1986
ABNORMAL SPINAL FLUID CONTROL
K863745 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 13d
Cleared Oct 07, 1986
ORTHO-BITE WAX WAFER
K863758 · EGD
Columbus Dental Mfg. Co.
Dental · 12d
Cleared Oct 06, 1986
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K853770 · GWM
Codman & Shurtleff, Inc.
Neurology · 392d
Cleared Oct 06, 1986
FEMORAL HEMI-HIP PROSTHESIS
K862460 · KWY
Orthopaedic Device Corp.
Orthopedic · 98d
Cleared Oct 06, 1986
SLEEP ANALYZING COMPUTER
K862527 · OLZ
Micro Tronics Corp.
Neurology · 96d