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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39217–39240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2013
ORTHOALIGN PLUS SYSTEM
K130387 · OLO
Orthalign, Inc.
Orthopedic · 266d
Cleared Nov 08, 2013
MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
K131275 · LTT
Siemens Helathcare Diagnostics, Inc.
Microbiology · 189d
Cleared Nov 08, 2013
ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
K131767 · ONN
Orthosensor, Inc.
Orthopedic · 144d
Cleared Nov 08, 2013
APNEALINK PRO
K131932 · MNR
Resmed Germany, Inc.
Anesthesiology · 134d
Cleared Nov 08, 2013
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
K132515 · CEW
DiaSorin, Inc.
Chemistry · 88d
Cleared Nov 08, 2013
MEDIVALVE ACWIRE
K132545 · DQX
Medivalve , Ltd.
Cardiovascular · 87d
Cleared Nov 08, 2013
PASS LP SPINAL SYSTEM
K132574 · OSH
Medicrea International
Orthopedic · 84d
Cleared Nov 08, 2013
VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10
K132913 · IYN
Ge Healthcare
Radiology · 52d
Cleared Nov 07, 2013
UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST,...
K131236 · LCX
Ucp Biosciences, Inc.
Chemistry · 190d
Cleared Nov 07, 2013
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
K131240 · LXB
Cochlear Americas
Ear, Nose, Throat · 190d
Cleared Nov 07, 2013
CONCEIVE PLUS
K131355 · PEB
Sasmar, Inc.
Obstetrics & Gynecology · 181d
Cleared Nov 07, 2013
G-ARM MULTISCAN SYSTEM
K131423 · OXO
Beijing East Whale Imaging Technology...
Radiology · 175d
Cleared Nov 07, 2013
DC 7
K131839 · GEX
Dc International, LLC
General & Plastic Surgery · 139d
Cleared Nov 07, 2013
KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
K131841 · LZA
Kimberly-Clark Corp.
General Hospital · 139d
Cleared Nov 07, 2013
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER...
K132006 · LZA
Hartalega Sdn Bhd
General Hospital · 129d
Cleared Nov 07, 2013
Merit ASAPLP Aspiration Catheter
K132155 · QEZ
Merit Medical Systems, Inc.
Cardiovascular · 118d
Cleared Nov 07, 2013
AQUILION ONE VISION, V6.0
K132222 · JAK
Toshibamedical Systems Corporation
Radiology · 113d
Cleared Nov 07, 2013
BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
K132456 · GQG
Becton, Dickinson and Company
Microbiology · 93d
Cleared Nov 07, 2013
CLARISO PACS
K132799 · LLZ
Clariso, Inc.
Radiology · 62d
Cleared Nov 06, 2013
UNISTRIP 1
K113135 · NBW
Unistrip Technologies, LLC
Chemistry · 744d
Cleared Nov 06, 2013
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
K130357 · BTG
Covidien, LLC
Ear, Nose, Throat · 266d
Cleared Nov 06, 2013
RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
K130405 · BWC
Teleflex Medical
Anesthesiology · 260d
Cleared Nov 06, 2013
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K130419 · MUH
Genoray Co., Ltd.
Radiology · 260d
Cleared Nov 06, 2013
ZTX ULTRASONIC DIATHERMY DEVICE
K130978 · PFW
Zetroz, Inc.
Physical Medicine · 211d