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

Filters: Cleared only ×
175,820 results
150169–150192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 1985
HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE
K844371 · GEI
Consolidated Medical Equipment, Inc.
General & Plastic Surgery · 99d
Cleared Feb 20, 1985
MODEL FORCE 2 ELECTROSURGICAL GENERATOR
K844403 · GEI
Valleylab, Inc.
General & Plastic Surgery · 99d
Cleared Feb 20, 1985
RADIOTOM 804
K844428 · GEI
Siemens Medical Solutions USA, Inc.
Radiology · 96d
Cleared Feb 20, 1985
PERIFLUX PF-2
K844631 · DPW
Medex, Inc.
Cardiovascular · 85d
Cleared Feb 20, 1985
ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON
K844856 · DRX
Bristol Medical Electronics Corp.
Cardiovascular · 68d
Cleared Feb 19, 1985
CARBON DIOXIDE LASER ML 825
K833528 · HHR
Merrimack Laboratories
Obstetrics & Gynecology · 515d
Cleared Feb 19, 1985
EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS
K842133 · FOZ
Cardio Search, Inc.
General Hospital · 265d
Cleared Feb 19, 1985
MODIFICATION OF ABL MIC-10 PRECEPT SYS
K843612 · LTD
Austin Biological Laboratories
Microbiology · 159d
Cleared Feb 19, 1985
LINEAR LIFT DEVICE
K844368 · IKK
Cybex
Physical Medicine · 98d
Cleared Feb 19, 1985
MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT
K844482 · JDL
Advanced Biosearch Assn.
Orthopedic · 92d
Cleared Feb 19, 1985
MECRON MRC-HEADLESS FEMORAL COMPONENT
K844486 · KWL
Mecron Medical Products, Inc.
Orthopedic · 92d
Cleared Feb 19, 1985
MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR
K844487 · KWL
Mecron Medical Products, Inc.
Orthopedic · 92d
Cleared Feb 19, 1985
HYDROSET ROOT CANAL SEALER
K844635 · KIF
Lund Manufacturing Co.
Dental · 83d
Cleared Feb 19, 1985
TRICON REVISION TOTAL KNEE SYSTEM
K844706 · HSX
Richards Medical Co., Inc.
Orthopedic · 78d
Cleared Feb 19, 1985
CLINIC ELECTRONIC THERMOMETER
K850564 · FLL
Gemini Electronics Co. , Ltd.
General Hospital · 7d
Cleared Feb 15, 1985
WHITE OCULAR PRESSURE RELIEF DEVICE
K840204 · KYF
Precision-Cosmet Co., Inc.
Ophthalmic · 393d
Cleared Feb 15, 1985
HOME PRO VOLUMETRIC INFUSION PUMP
K841374 · FRN
American Edwards Laboratories
General Hospital · 318d
Cleared Feb 15, 1985
NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE
K843596 · HLI
Nidek, Inc.
Ophthalmic · 156d
Cleared Feb 15, 1985
NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE
K843597 · HLI
Nidek, Inc.
Ophthalmic · 156d
Cleared Feb 15, 1985
CARE ELECTRIC BREAST PUMP
K844013 · HGX
Hankscraft Div. of Gerber Products Co.
Obstetrics & Gynecology · 126d
Cleared Feb 15, 1985
OVUDATE
K844043 · LHD
Joel R.L. Ehren Kranz
Obstetrics & Gynecology · 121d
Cleared Feb 15, 1985
NUTRIMIX EMPTY CONTAINER
K844077 · KPE
Abbott Laboratories
General Hospital · 119d
Cleared Feb 15, 1985
OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR
K844277 · DXG
Omikron Scientific, Ltd.
Cardiovascular · 102d
Cleared Feb 15, 1985
FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD
K844750 · FKQ
Seratronics, Inc.
Gastroenterology & Urology · 71d