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
51217–51240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2010
R650 QDASM COLLIMATOR
K093572 · IZW
Omega Medical Imaging, Inc.
Radiology · 77d
Cleared Feb 02, 2010
ATLAS INTERVERTEBRAL BODY CAGE
K092774 · MAX
Spinal Edge, LLC
Orthopedic · 146d
Cleared Feb 02, 2010
GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H
K092970 · MHX
General Meditech, Inc.
Cardiovascular · 130d
Cleared Feb 02, 2010
DEPUY FRACTURE AND FUSION PLATING SYSTEM
K093474 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 88d
Cleared Feb 02, 2010
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER,...
K100063 · MJN
Ev3, Inc.
Cardiovascular · 22d
Cleared Feb 02, 2010
IMPLANTABLE CLIP
K100090 · FZP
Genicon
General & Plastic Surgery · 21d
Cleared Feb 02, 2010
EVOLVE EPS ORTHOLOC
K100146 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 14d
Cleared Feb 01, 2010
EC50 MICRO+ SMOKERLYZER
K082315 · CCJ
Bedfont Scientific, Ltd.
Toxicology · 537d
Cleared Feb 01, 2010
FLEXPEN NEEDLE
K090111 · FMI
Novo Nordisk, Inc.
General Hospital · 381d
Cleared Feb 01, 2010
QUANTA LITE APS/PT IGG AND IGM ELISA
K090755 · OPN
Inova Diagnostics, Inc.
Immunology · 318d
Cleared Feb 01, 2010
TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021
K092821 · GCJ
Agency For Medical Innovations, Inc.
General & Plastic Surgery · 140d
Cleared Feb 01, 2010
LAP LOOP
K092897 · KNF
Medsys, S.A.
Obstetrics & Gynecology · 133d
Cleared Feb 01, 2010
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE...
K093112 · GAW
Coloplast Manufacturing Us, LLC
General & Plastic Surgery · 123d
Cleared Feb 01, 2010
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
K093284 · MOS
Invivo Corporation
Radiology · 104d
Cleared Feb 01, 2010
GEM FLOW COUPLER DEVICE AND SYSTEM
K093310 · MVR
Synovis Micro Companies Alliance, Inc.
General & Plastic Surgery · 102d
Cleared Feb 01, 2010
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
K093563 · IYN
Philips Ultrasound, Inc.
Radiology · 75d
Cleared Feb 01, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR
K093727 · LYZ
Zibo Bolin Gloves Co., Ltd.
General Hospital · 60d
Cleared Jan 29, 2010
URSA ANGIOGRAPHIC CATHETER
K090427 · DQO
Curative Medical Technology, Inc.
Cardiovascular · 344d
Cleared Jan 29, 2010
STATNET, MODEL 3100
K092828 · GXY
Hydrodot, Inc.
Neurology · 137d
Cleared Jan 29, 2010
TRILOGY 200 VENTILATOR
K093416 · CBK
Respironics, Inc.
Anesthesiology · 88d
Cleared Jan 29, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557
K100014 · DXN
Andon Health Co, Ltd.
Cardiovascular · 25d
Cleared Jan 29, 2010
R & D SYSTEMS XERET HEMATOLOGY CONTROL
K100050 · JPK
R&D Systems, Inc.
Hematology · 21d
Cleared Jan 29, 2010
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR
K100117 · IPF
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 14d
Cleared Jan 28, 2010
VALEO SPACER SYSTEM
K091278 · MAX
Amedica Corp.
Orthopedic · 272d