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
36241–36264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2014
MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
K142022 · NLY
Medline Renewal
Ear, Nose, Throat · 147d
Cleared Dec 19, 2014
POROSTEON PHUSION METAL CERVICAL CAGE
K142041 · ODP
Porosteon, Inc.
Orthopedic · 144d
Cleared Dec 19, 2014
ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS...
K142111 · JDR
Novatsep
Orthopedic · 137d
Cleared Dec 19, 2014
PK NEEDLE
K142154 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 135d
Cleared Dec 19, 2014
CytoSure Urinary Access System
K142194 · FAJ
Emmy Medical
Gastroenterology & Urology · 130d
Cleared Dec 19, 2014
Bioceptive Suction Cervical Retractor
K142204 · HDC
Bioceptive, Inc.
Obstetrics & Gynecology · 130d
Cleared Dec 19, 2014
Zavation Z-Link Lumbar
K142271 · OVD
Zavation, LLC
Orthopedic · 126d
Cleared Dec 19, 2014
Connex Spot Monitor,901058 Vital Signs Monitor Core
K142356 · MWI
Welch Allyn, Inc.
Cardiovascular · 116d
Cleared Dec 19, 2014
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access...
K142362 · MRG
Beckman Coulter, Inc.
Chemistry · 116d
Cleared Dec 19, 2014
Hi-Torque JET Guide Wire Family
K142415 · DQX
Abbott Vascular, Inc.
Cardiovascular · 113d
Cleared Dec 19, 2014
LIFEPAK 15 monitor/defibrillator
K142430 · MKJ
Physio-Control, Inc.
Cardiovascular · 112d
Cleared Dec 19, 2014
S12 Digital Color Doppler Ultrasound System
K142474 · IYN
Sonoscape Company Limited
Radiology · 107d
Cleared Dec 19, 2014
TurboSEAL Nasogastric Aspiration Tube
K142483 · BSS
Turboseal, L.P.
Gastroenterology & Urology · 106d
Cleared Dec 19, 2014
Powder Free Yellow Vinyl Patient Examination Gloves
K142508 · LYZ
Zibo Huaqi Trading Co., Ltd.
General Hospital · 102d
Cleared Dec 19, 2014
ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)
K142638 · GEX
Innovaquartz, LLC
General & Plastic Surgery · 93d
Cleared Dec 19, 2014
Echotip Procore HD Ultrasound Biopsy Needle
K142688 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 88d
Cleared Dec 19, 2014
InsufflatOR Needle
K142700 · HIF
Gynetech Pty. , Ltd.
Obstetrics & Gynecology · 88d
Cleared Dec 19, 2014
SMD Sr90-1 Radionuclide Brachytherapy Source
K142701 · KXK
Salutaris Medical Devices, Inc.
Radiology · 88d
Cleared Dec 19, 2014
AIS Odontoid Fracture Fixation System
K142707 · HWC
Aesculap Implant System, Inc.
Orthopedic · 88d
Cleared Dec 19, 2014
artus HSV-1/2 QS-RGQ MDx Kit
K142738 · OQO
Qiagen
Microbiology · 87d
Cleared Dec 19, 2014
Weck Hem-o-lok Auto Endo5 Ligating Clip Applier
K142777 · FZP
Teleflexmedical, Inc.
General & Plastic Surgery · 84d
Cleared Dec 19, 2014
RhythmView Workstation
K142901 · DQK
Topera, Inc.
Cardiovascular · 66d
Cleared Dec 19, 2014
Legacy BX
K142910 · GEI
Venus Concept USA, Inc.
General & Plastic Surgery · 74d
Cleared Dec 19, 2014
HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
K142942 · HSD
Arthrosurface, Inc.
Orthopedic · 66d