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
81769–81792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2000
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
K001646 · CBK
Puritan Bennett Corp.
Anesthesiology · 143d
Cleared Oct 20, 2000
WACKERS-LIU CQ SOFTWARE
K002229 · KPS
Eclipse Systems, Inc.
Radiology · 88d
Cleared Oct 20, 2000
LACTOSORB PUSH SCREW
K002423 · DZL
Biomet, Inc.
Dental · 73d
Cleared Oct 20, 2000
STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
K002547 · HQP
Starion Instruments
Ophthalmic · 64d
Cleared Oct 20, 2000
DURAGARD SODIUM FLUORIDE VARNISH
K002581 · LBH
Sultan Dental Products, Ltd.
Dental · 63d
Cleared Oct 20, 2000
DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K002814 · LYZ
Shanghai PM Plastics Enterise Co., Ltd.
General Hospital · 39d
Cleared Oct 20, 2000
NICHOLS ADVANTAGE THYROGLOB
K002888 · MSW
Nichols Institute Diagnostics
Immunology · 35d
Cleared Oct 20, 2000
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC
K002949 · DSP
Datascope Corp.
Cardiovascular · 29d
Cleared Oct 20, 2000
BACT/ALERT CSR
K003104 · LJF
Organon Teknika Corp.
Microbiology · 52d
Cleared Oct 20, 2000
MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS
K003121 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Oct 20, 2000
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K003125 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Oct 20, 2000
VISIJET HYDROKERATOME, MODEL 50
K991124 · MYD
Visijet, Inc.
Ophthalmic · 567d
Cleared Oct 20, 2000
BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/...
K994276 · LZA
Biopro (M) Sdn Bhd
General Hospital · 305d
Cleared Oct 20, 2000
BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN,...
K994281 · LZA
Biopro (M) Sdn Bhd
General Hospital · 305d
Cleared Oct 20, 2000
CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
K994320 · NCZ
Cantor & Silver , Ltd.
Ophthalmic · 303d
Cleared Oct 19, 2000
0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE
K000632 · FOZ
Avitro, LLC
General Hospital · 238d
Cleared Oct 19, 2000
MACROPOREMX MANDIBULAR FIXATION SYSTEM
K000696 · JEY
Macropore Biosurgery, Inc.
Dental · 232d
Cleared Oct 19, 2000
IMPOAID
K000730 · LKY
Impoaid, Inc.
Gastroenterology & Urology · 227d
Cleared Oct 19, 2000
TREPCHEK TREPONEMAL ANTIBODY EIA
K001552 · LIP
Phoenix Biotech Corp.
Microbiology · 154d
Cleared Oct 19, 2000
GLOBAL SPINAL FIXATION SYSTEM
K001668 · MNH
D.K.M. Co., Ltd.
Orthopedic · 141d
Cleared Oct 19, 2000
THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD
K001795 · FOZ
Avitro, LLC
General Hospital · 127d
Cleared Oct 19, 2000
GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
K002169 · MST
Scimedx Corp.
Immunology · 93d
Cleared Oct 19, 2000
GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
K002189 · MST
Scimedx Corp.
Immunology · 92d
Cleared Oct 19, 2000
TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100
K002257 · GEI
Tecno Instruments (Pvt.) , Ltd.
General & Plastic Surgery · 86d