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
40321–40344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2013
STRAWBERRY, STRAWBERRY & CREAM
K130341 · OLI
Laser Lipo Limited
General & Plastic Surgery · 207d
Cleared Sep 06, 2013
FREEMIE BREAST COLLECTION SYSTEM
K130349 · HGX
Dao Health
Obstetrics & Gynecology · 206d
Cleared Sep 06, 2013
ALIVECOR HEART MONITOR
K130409 · DPS
AliveCor, Inc.
Cardiovascular · 199d
Cleared Sep 06, 2013
XPERCT REL. 3
K130893 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 158d
Cleared Sep 06, 2013
LIAISON XL HCG
K131037 · DHA
DiaSorin, Inc.
Chemistry · 144d
Cleared Sep 06, 2013
PEAK Z
K131357 · KLE
Ultradent Products, Inc.
Dental · 119d
Cleared Sep 06, 2013
JUSHA-C31 MEDICAL DISPLAY
K131389 · LLZ
Nanjing Jusha Display Technology Co.,...
Radiology · 115d
Cleared Sep 06, 2013
FIRECR DENTALIMAGING SYSTEM
K131442 · MUH
3Disc Americas
Radiology · 109d
Cleared Sep 06, 2013
GORE SEAMGUARD REINFORCEMENT
K131658 · OXC
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 92d
Cleared Sep 06, 2013
EYESEECAM VHIT
K131681 · GWN
Interacoustics A/S
Neurology · 88d
Cleared Sep 06, 2013
QUIDEL MOLECULAR RSV + HMPV ASSAY
K131813 · OCC
Quidel Corp.
Microbiology · 78d
Cleared Sep 06, 2013
SINGLE USE GROUNDING PAD
K132136 · GEI
Lccs Products Limited
General & Plastic Surgery · 57d
Cleared Sep 06, 2013
K-PACK II NEEDLE - 27G X 3/4 THIN WALL
K132233 · FMI
Terumo Europe N.V.
General Hospital · 50d
Cleared Sep 06, 2013
COMPREHENSIVE REVERSE SHOULDER SCREWS
K132239 · PHX
Biomet Manufacturing Corp
Orthopedic · 50d
Cleared Sep 06, 2013
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE...
K132324 · KWQ
Medos International SARL
Orthopedic · 42d
Cleared Sep 06, 2013
THERMAGE CPT SYSTEM
K132431 · GEI
Solta Medical, Inc.
General & Plastic Surgery · 32d
Cleared Sep 05, 2013
SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
K123723 · GWO
Synthes
Neurology · 275d
Cleared Sep 05, 2013
STITCHKIT
K123811 · NBY
Origami Surgical, LLC
General & Plastic Surgery · 268d
Cleared Sep 05, 2013
KOSTEC MEDICAL GRADE LDC MONITORS
K123944 · LLZ
Kostec Co., Ltd.
Radiology · 259d
Cleared Sep 05, 2013
ARIX FOOT SYSTEM
K131311 · HRS
Jeil Medical Corporation
Orthopedic · 121d
Cleared Sep 05, 2013
PRESSUREWIRE
K131452 · DXO
St. Jude Medical Systems AB
Cardiovascular · 108d
Cleared Sep 05, 2013
Z5MLB, Z5MLC
K131701 · DZE
Z-Systems AG
Dental · 86d
Cleared Sep 05, 2013
ACUMED WRIST SPANNING PLATE
K131764 · HRS
Acumed, LLC
Orthopedic · 80d
Cleared Sep 05, 2013
TEPHAFLEX BRAIDED SUTURE
K132348 · NWJ
Tepha, Inc.
General & Plastic Surgery · 38d