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
33505–33528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2015
Aerin Medical Wand Model FG011
K150637 · GEI
Aerin Medical, Inc.
General & Plastic Surgery · 253d
Cleared Nov 19, 2015
AN1087 Dosimeter
K150645 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 252d
Cleared Nov 19, 2015
Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R)...
K150799 · FRO
Innovacyn, Inc.
General & Plastic Surgery · 238d
Cleared Nov 19, 2015
Medihoney Wound Gel
K150985 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 219d
Cleared Nov 19, 2015
Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
K151296 · PBX
Bios S.R.L.
General & Plastic Surgery · 188d
Cleared Nov 19, 2015
Cytoflex Tefguard Ti-Enforced Membrane
K151344 · NPK
Unicare Biomedical, Inc.
Dental · 184d
Cleared Nov 19, 2015
SNaP Wound Care System
K151710 · OKO
Spiracur, Inc.
General & Plastic Surgery · 148d
Cleared Nov 19, 2015
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and...
K151791 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 141d
Cleared Nov 19, 2015
TLC-2000 Therapeutic Medical Laser System
K151816 · NHN
Theralase, Inc.
Physical Medicine · 136d
Cleared Nov 19, 2015
InFill Interbody Fusion Device
K152259 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 100d
Cleared Nov 19, 2015
Tritanium PL Cage
K152304 · MAX
Stryker
Orthopedic · 97d
Cleared Nov 19, 2015
Visions PV.014P RX Digital IVUS Catheter
K152829 · OBJ
Volcano Corporation
Cardiovascular · 51d
Cleared Nov 19, 2015
BladderScan Prime System
K153101 · IYO
Verathon Incorporated
Radiology · 24d
Cleared Nov 18, 2015
Invisalign System
K143630 · NXC
Align Technology, Inc.
Dental · 331d
Cleared Nov 18, 2015
AN85/AN86 EO Indicators
K150644 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 251d
Cleared Nov 18, 2015
EOGas 4 Ethylene Oxide Gas Sterilizer
K150646 · FLF
Andersen Sterilizers, Inc.
General Hospital · 251d
Cleared Nov 18, 2015
WASTON General Spinal System
K150684 · MNI
Changzhou Waston Medical Appliance...
Orthopedic · 246d
Cleared Nov 18, 2015
R350 guidewire
K151234 · DQX
Vascular Solutions, Inc.
Cardiovascular · 194d
Cleared Nov 18, 2015
Andersen EOGas 4 SteriTest
K151585 · FRC
Andersen Sterilizers, Inc.
General Hospital · 160d
Cleared Nov 18, 2015
Tyvek Sterilization Pouches with Chevron Seal
K152058 · FRG
Andersen Sterilizers, Inc.
General Hospital · 117d
Cleared Nov 18, 2015
Clickfine AutoProtect Pen Needle
K152514 · FMI
Ypsomed AG
General Hospital · 77d
Cleared Nov 18, 2015
8 CH Knee SPEEDER
K152695 · MOS
Quality Electrodynamics, LLC
Radiology · 58d
Cleared Nov 18, 2015
Venue 50
K152758 · IYN
GE Medical Systems Ultrasound and...
Radiology · 55d
Cleared Nov 18, 2015
Philips IntelliSpace Cardiovascular
K153022 · LLZ
Philips Medical Systems Nethrlands BV
Radiology · 34d