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
31249–31272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2016
Erbe’s CO2 Tubing/Cap Sets
K162152 · FEQ
Erbe USA, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 30, 2016
Halo II Ambulatory Infusion System (also with trade names Nimbus II...
K153193 · FRN
Zyno Medical, LLC
General Hospital · 301d
Cleared Aug 30, 2016
Miret Grasper, Alligator, Miret Grasper, Maryland
K160149 · OCW
Miret Surgical, Inc.
Gastroenterology & Urology · 222d
Cleared CT Aug 30, 2016
OnSight 3D Extremity System
K160723 · JAK
Carestream Health, Inc.
Radiology · 167d
Cleared Aug 30, 2016
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
K161251 · DKZ
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 119d
Cleared Aug 30, 2016
ANAX™ 5.5 Spinal System
K162189 · MNH
U&I Corporation
Orthopedic · 26d
Cleared Aug 29, 2016
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu...
K152931 · BTM
Ambu A/S
Anesthesiology · 329d
Cleared Aug 29, 2016
Insulin Pen Needle
K153706 · FMI
SteriLance Medical (Suzhou), Inc.
General Hospital · 250d
Cleared Aug 29, 2016
INDEPENDENCE MIS Spacers
K160597 · OVD
Globus Medical, Inc.
Orthopedic · 180d
Cleared Aug 29, 2016
ATLANTIS Abutment for HIOSSEN ET implant
K160626 · NHA
Dentsply Sirona
Dental · 175d
Cleared Aug 29, 2016
Arthrex VaultLock Glenoid
K161108 · KWS
Arthrex, Inc.
Orthopedic · 131d
Cleared Aug 29, 2016
Digital Thermometer
K161211 · FLL
Biocare Asia Corporation , Ltd.
General Hospital · 123d
Cleared Aug 29, 2016
USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium...
K161311 · FRO
Strukmyer Medical, LLC
General & Plastic Surgery · 111d
Cleared Aug 29, 2016
Philips Avent Comfort Single/Twin Electric Breast Pump
K161532 · HGX
Philips Consumer Lifestyle -...
Obstetrics & Gynecology · 88d
Cleared Aug 29, 2016
Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing...
K161570 · OMP
Lc Medical Concepts, Inc.
General & Plastic Surgery · 83d
Cleared Aug 29, 2016
Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I,...
K161619 · OUY
Cepheid
Microbiology · 77d
Cleared Aug 29, 2016
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
K161777 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 61d
Cleared Aug 29, 2016
UreTron PF Series Probe
K162119 · FFK
Med-Sonics Corp.
Gastroenterology & Urology · 28d
Cleared Aug 26, 2016
CompleClear Plastic Orthodontic Bracket and Wire Appliance
K150830 · DYW
Oracrew
Dental · 515d
Cleared Aug 26, 2016
Skypro, SP01 Mask
K152197 · FXX
Skypro Medical Supplies Company
General Hospital · 387d
Cleared Aug 26, 2016
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
K152642 · GXI
Lccs Products Limited
Neurology · 346d
Cleared Aug 26, 2016
GPS Angled Abutment
K153509 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 263d
Cleared Aug 26, 2016
OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy...
K153559 · IMG
Accelerated Care Plus (Acp)
Physical Medicine · 256d
Cleared Aug 26, 2016
LUNA DENTAL IMPLANT SYSTEM
K160106 · DZE
Shinhung Mst Co., Ltd.
Dental · 220d