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

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175,820 results
35113–35136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2015
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x...
K150946 · LIT
Ostial Corporation
Cardiovascular · 30d
Cleared May 08, 2015
21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
K151007 · PGY
Jvckenwood Corporation
Radiology · 23d
Cleared May 07, 2015
MRI PATIENT MONITORING SYSTEM TESLA M3
K142032 · MWI
Mipm Mammendorfer Institut Fur Physik...
Cardiovascular · 286d
Cleared May 07, 2015
Insightra Freedom Ventral Hernia Repair System
K142192 · FTL
Insightra Medical
General & Plastic Surgery · 269d
Cleared May 07, 2015
The Vest Airway Clearance System
K142482 · BYI
Hill-Rom Services Private Limited
Anesthesiology · 245d
Cleared May 07, 2015
Chesapeake Stabilization System
K142487 · OVD
K2m, Inc.
Orthopedic · 245d
Cleared May 07, 2015
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case,...
K142717 · LRX
Ni Hau Industrial Co., Ltd.
Ophthalmic · 226d
Cleared May 07, 2015
Mecta-C TiPEEK
K142744 · ODP
Medacta International
Orthopedic · 225d
Cleared May 07, 2015
Gemini Bonded Sterilization Wrap
K143147 · FRG
Medline Industries, Inc.
General Hospital · 185d
Cleared May 07, 2015
entré Model PD08-U
K143185 · JOW
Tactile Systems Technology, Inc.
Cardiovascular · 183d
Cleared May 07, 2015
FORA GD43 Blood Glucose Monitoring System
K143467 · NBW
Taidoc Technology Corporation
Chemistry · 154d
Cleared May 07, 2015
GC KommonBase
K143667 · DYH
Gc Orthodontics America, Inc.
Dental · 135d
Cleared May 07, 2015
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring...
K143750 · CGA
Apex BioTechnology Corp.
Chemistry · 127d
Cleared May 07, 2015
JAZZ System
K143759 · OWI
Implanet, S.A.
Orthopedic · 127d
Cleared May 07, 2015
Blue Mountain Cervical Plate System
K150036 · KWQ
Spineway
Orthopedic · 118d
Cleared May 07, 2015
QUADROX-i Adult/Small Adult Oxygenators
K150267 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 92d
Cleared May 07, 2015
Tensyn Plug
K150359 · HTN
Dallen Medical, Inc.
Orthopedic · 84d
Cleared May 07, 2015
Diagnostic X-ray System
K150663 · KPR
Osko, Inc.
Radiology · 52d
Cleared May 07, 2015
Elite L Expandable Lumbar Fusion System
K150954 · MAX
Innova Spinal Technologies, LLC
Orthopedic · 28d
Cleared May 06, 2015
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
K143434 · MSS
Abbott Medical Optics, Inc.
Ophthalmic · 156d
Cleared May 06, 2015
Electric Breast Pump
K143585 · HGX
Shantou Xinghe Electrical Apparatuses...
Obstetrics & Gynecology · 139d
Cleared May 06, 2015
Luxisse+
K150056 · EIH
Heany Industries, Inc.
Dental · 114d
Cleared May 06, 2015
StatStrip Glucose Hospital Meter
K150281 · PZI
Nova Biomedical Corporation
Chemistry · 90d
Cleared May 06, 2015
Spiral Flow Peripheral Vascular Graft
K150389 · DSY
Vascular Flow Technologies, Ltd.
Cardiovascular · 77d