FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90385–90408 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1998
AFFINITY MEDICAL PATIENT CABLE SYSTEM
K980806 · DSA
Affinity Medical Technologies, LLC
Cardiovascular · 22d
Cleared Mar 24, 1998
ASTRA TECH IMPLANT DENTAL SYSTEM
K974737 · DZE
Astra Tech, Inc.
Dental · 95d
Cleared Mar 24, 1998
BRANEMARK SYSTEM(R) EBON(TM) FIXTURE
K974828 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared Mar 24, 1998
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
K974906 · KLE
Coltene/Whaledent, Inc.
Dental · 83d
Cleared Mar 24, 1998
3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000
K980089 · FRN
Valley West, Inc.
General Hospital · 74d
Cleared Mar 24, 1998
ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)
K980090 · LJS
Luther Medical Products, Inc.
General Hospital · 74d
Cleared Mar 24, 1998
QUANTA LITE B2 GPI SCREEN
K980230 · MSV
Inova Diagnostics, Inc.
Immunology · 61d
Cleared Mar 24, 1998
IP-16
K980301 · BTA
Servizi Medico Estetici Italinai Srl.
General & Plastic Surgery · 56d
Cleared Mar 24, 1998
AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR...
K980574 · JLW
Alfa Biotech (Uk) , Ltd.
Chemistry · 35d
Cleared Mar 23, 1998
MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)
K971910 · DSI
Hewlett-Packard GmbH
Cardiovascular · 304d
Cleared Mar 23, 1998
HURRISEAL DENTIN DESENSITIZER
K973002 · KLE
Cheng & Assoc., Inc.
Dental · 223d
Cleared Mar 23, 1998
MERCURY DENTAL
K973548 · ELY
Aleaciones Dentales Zeyco, S.A. DE C.V.
Dental · 186d
Cleared Mar 23, 1998
ROUND WINDOW E-CATH
K973740 · ETD
Neuro-Biometrix, Inc.
Ear, Nose, Throat · 173d
Cleared Mar 23, 1998
THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
K974679 · IZI
Medcon , Ltd.
Radiology · 98d
Cleared Mar 23, 1998
VYGON NEO-SUMP
K974806 · KNT
Vygon Corp.
Gastroenterology & Urology · 90d
Cleared Mar 23, 1998
SELECTCELLS(TM) MINI
K974819 · HHK
Select Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 23, 1998
METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K980218 · LPL
Biocompatibles Eyewear, Inc.
Ophthalmic · 66d
Cleared Mar 23, 1998
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
K980488 · HQE
Storz Instrument Co.
Ophthalmic · 42d
Cleared Mar 23, 1998
ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
K980533 · EWO
Etymotic Research
Ear, Nose, Throat · 40d
Cleared Mar 23, 1998
SOLOBOND M
K980539 · KLE
Voco GmbH
Dental · 39d
Cleared Mar 23, 1998
TRIMAX RADIOGRAPHIC CASSETTE
K980722 · IXA
Imation Corp.
Radiology · 27d
Cleared Mar 20, 1998
TOWNLEY PEDICLE SCREW PLATING SYSTEM
K970599 · MNI
Danek Medical, Inc.
Orthopedic · 395d
Cleared Mar 20, 1998
MICRO-STRIP FOR AMPHETAMINE METABOLITES
K974611 · DKZ
Microdiagnostics, Inc.
Toxicology · 99d
Cleared Mar 20, 1998
CRE(TM) BALLOON DILATATION CATHETER
K974788 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 88d