FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
69073–69096 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 2004
COMPREHENSIVE NEUROMUSCULAR PROFILER
K031995 · IKN
Medical Technologies Unlimited, Inc.
Neurology · 194d
Cleared Jan 07, 2004
PREMIER PLUS
K032003 · GZJ
American Imex
Neurology · 194d
Cleared Jan 07, 2004
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K032031 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 190d
Cleared Jan 07, 2004
SEA-BAND
K033268 · MVV
Sea-Band UK , Ltd.
Neurology · 90d
Cleared Jan 07, 2004
SPINEASSIST DEVICE
K033413 · HAW
Mazor Surgical Technologies , Ltd.
Neurology · 72d
Cleared Jan 07, 2004
PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
K033449 · EJR
Professional Dental Technologies...
Dental · 70d
Cleared Jan 07, 2004
GENESIS VERTICAL PLATFORM LIFT
K033469 · ING
Garaventa Accessibility
Physical Medicine · 65d
Cleared Jan 07, 2004
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
K033475 · OLV
Nihon Kohden America, Inc.
Neurology · 65d
Cleared Jan 07, 2004
LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
K033535 · PDU
Lumend, Inc.
Cardiovascular · 58d
Cleared Jan 07, 2004
VNUS VESSEL AND TISSUE COAGULATION SYSTEM
K033547 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 56d
Cleared Jan 07, 2004
STORZ RANEY SCALP CLIP, MODEL 1-20-004-05
K033660 · HBO
Rudolf Storz GmbH
Neurology · 47d
Cleared Jan 07, 2004
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K033922 · DZE
Institut Straumann AG
Dental · 20d
Cleared Jan 07, 2004
ELECSYS PRECICONTROL MULTIANALYTE
K033937 · JJY
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Jan 06, 2004
CODA CX1 MOTION ANALYSIS SYSTEM
K033514 · LXJ
Charnwood Dynamics , Ltd.
Physical Medicine · 61d
Cleared Jan 06, 2004
VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK
K033659 · DKZ
Varian, Inc.
Toxicology · 46d
Cleared Jan 02, 2004
NOVA GLUCOSE CONTROL SOLUTIONS
K033433 · JJX
Nova Biomedical Corp.
Chemistry · 66d
Cleared Jan 02, 2004
HEMOSIL LIQUID ANTITHROMBIN XL
K033775 · JBQ
Instrumentation Laboratory CO
Hematology · 30d
Cleared Jan 02, 2004
OMNILINK .018 BILIARY STENT SYSTEM
K033834 · FGE
Guidant Corp.
Gastroenterology & Urology · 23d
Cleared Dec 31, 2003
GEN-PROBE APTIMA COMBO 2 ASSAY
K032554 · LSL
Gen-Probe, Inc.
Microbiology · 134d
Cleared Dec 31, 2003
KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)
K033242 · HSH
Imaging Therapeutics, Inc.
Orthopedic · 85d
Cleared Dec 31, 2003
AMS LARGE PORE POLYPROPYLENE MESH
K033636 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 42d
Cleared Dec 31, 2003
GORE BIOABSORBABLE MESH
K033671 · OWT
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 37d
Cleared Dec 31, 2003
BIOANCHOR WITH DISPOSABLE DRIVER
K033804 · HWC
Linvatec Corp.
Orthopedic · 23d
Cleared Dec 30, 2003
HEMEDEX FIXATION DEVICE
K032127 · KNY
Hemedex Incorporated
Gastroenterology & Urology · 173d