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
35905–35928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2015
VECTRAPLEX CMS
K140852 · MSX
Vectracor, Inc.
Cardiovascular · 302d
Cleared Jan 30, 2015
SOMNOTOUCH RESP
K140861 · MNR
Somnomedics GmbH
Anesthesiology · 302d
Cleared Jan 30, 2015
NANOBONE / GRANULATE
K141189 · MQV
Artoss GmbH
Orthopedic · 267d
Cleared Jan 30, 2015
NAVAJO PTA BALLOON DILATATION CATHETER
K141354 · DQY
Curative Medical, Inc.
Cardiovascular · 252d
Cleared Jan 30, 2015
HIGH TIBIAL OSTEOTOMY SYSTEM
K141548 · HRS
Newclip Technics
Orthopedic · 233d
Cleared Jan 30, 2015
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE...
K141751 · MOF
Asahi Intecc Co., Ltd.
Neurology · 214d
Cleared Jan 30, 2015
ELUX 810 LASER
K141986 · GEX
Equipmed North America, Inc.
General & Plastic Surgery · 192d
Cleared Jan 30, 2015
EmboGuide
K142273 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 168d
Cleared Jan 30, 2015
Ideal pedicle screw spinal system
K142957 · MNH
Jiangsu Ideal Medical Science &...
Orthopedic · 108d
Cleared Jan 30, 2015
FilmArray Blood Culture Identification (BCID) Panel for use with the...
K143171 · PEN
Biofire Diagnostics, LLC
Microbiology · 87d
Cleared Jan 30, 2015
FilmArray 2.0 System
K143178 · NSU
Biofire Diagnostics, LLC
Microbiology · 87d
Cleared Jan 30, 2015
The LINK® Endo-Model® Knee System
K143179 · KRO
Waldemar Link GmbH & Co. KG
Orthopedic · 87d
Cleared Jan 30, 2015
Universal Digital Interface 2W, UDI 2W
K143232 · MQB
Meridian Medical Systems, LLC
Radiology · 81d
Cleared Jan 30, 2015
Prelude PF Patellae
K143543 · KRR
Biomet, Inc.
Orthopedic · 46d
Cleared Jan 30, 2015
CREO Stabilization System
K143633 · NKB
Globus Medical, Inc.
Orthopedic · 39d
Cleared Jan 29, 2015
TRANSONIC ELSA SYSTEM
K134051 · DXG
Transonic Systems, Inc.
Cardiovascular · 394d
Cleared Jan 29, 2015
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
K141210 · LLL
Inova Diagnostics, Inc.
Immunology · 265d
Cleared Jan 29, 2015
LightStim for Acne/ LightStim for Acne Mini
K142246 · OLP
Led Intellectual Properties, LLC
General & Plastic Surgery · 168d
Cleared Jan 29, 2015
One Way Soft Valve
K142500 · MJJ
Terumo Cardiovascular Systems...
Cardiovascular · 146d
Cleared Jan 29, 2015
Surgical Gut Suture
K142656 · GAL
Covidien
General & Plastic Surgery · 133d
Cleared Jan 29, 2015
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
K142714 · IYN
Sonoscape Company Limited
Radiology · 129d
Cleared Jan 29, 2015
HEINE SIGMA 250 & HEINE SIGMA 250 M2
K142837 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 121d
Cleared Jan 29, 2015
Mini ONE Enteral Extension Set
K142989 · PIF
Applied Medical Technology, Inc.
Gastroenterology & Urology · 105d
Cleared Jan 29, 2015
easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler
K143129 · GDW
Ezisurg Medical Co., Ltd.
General & Plastic Surgery · 90d