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
46129–46152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2011
AMS ELEVATE PC
K112842 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 26d
Cleared Oct 24, 2011
NANOKNIFE SYSTEM
K102329 · OAB
AngioDynamics, Inc.
General & Plastic Surgery · 433d
Cleared Oct 24, 2011
MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES
K102387 · JDR
Mediscope Manufacturing, Inc.
Orthopedic · 427d
Cleared Oct 24, 2011
LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT
K103513 · HRS
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 328d
Cleared Oct 24, 2011
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
K110569 · MLO
Inovise Medical, Inc.
Cardiovascular · 238d
Cleared Oct 24, 2011
VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
K110783 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 217d
Cleared Oct 24, 2011
WINGEATER V2
K111948 · FIE
JMS North America Corporation
Gastroenterology & Urology · 108d
Cleared Oct 24, 2011
FRAMEWALKER
K111993 · KTT
Quantum Medical Concepts, LLC
Orthopedic · 103d
Cleared Oct 24, 2011
SOFIA ANALYZER AND INFLUENZA A+B FIA
K112177 · PSZ
Quidel Corp.
Microbiology · 88d
Cleared Oct 24, 2011
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
K112497 · DTK
C.R. Bard, Inc.
Cardiovascular · 56d
Cleared Oct 24, 2011
PATIENT MONITOR
K112803 · MHX
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 27d
Cleared Oct 21, 2011
VRESELECT CULTURE MEDIUM
K103684 · JSO
Bio-Rad
Microbiology · 308d
Cleared Oct 21, 2011
PHYSIOGLOVE ES WITH ECG ANALYSIS
K103791 · DPS
Commwell , Ltd.
Cardiovascular · 298d
Cleared Oct 21, 2011
ENSPIRE DEBRIDER SYSTEM
K110992 · HRX
Spine View, Inc.
Orthopedic · 196d
Cleared Oct 21, 2011
E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
K111030 · EOX
Intromedic Co., Ltd.
Ear, Nose, Throat · 191d
Cleared Oct 21, 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE
K111639 · KDI
Fresenius Medical Care
Gastroenterology & Urology · 130d
Cleared Oct 21, 2011
AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
K111854 · DRG
St. Jude Medical Systems AB
Cardiovascular · 114d
Cleared Oct 21, 2011
ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
K112166 · GEX
W and R Investments Dba Laser...
General & Plastic Surgery · 85d
Cleared Oct 21, 2011
REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER
K112292 · NLH
Stryker Sustainability Solutions
Cardiovascular · 72d
Cleared Oct 21, 2011
LIFECARE ARM & LEG PAIN RELIEF SYSTEM
K112415 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 60d
Cleared Oct 21, 2011
CD HORIZON SPINAL SYSTEM
K112473 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 56d
Cleared Oct 21, 2011
DIOSLIMON IMPLANT SYSTEM
K112746 · DZE
Dio Corporation
Dental · 30d
Cleared Oct 20, 2011
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
K101286 · BZR
Linde Healthcare AB
Anesthesiology · 531d
Cleared Oct 20, 2011
QUADRA BLOC TENS PLUS
K102278 · GZJ
Gradient Technologies, LLC
Neurology · 435d