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
43681–43704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2012
IO-TOME DEVICE
K113073 · HAE
Baxano, Inc.
Neurology · 284d
Cleared Jul 27, 2012
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
K113307 · LFR
Hmd Biomedical, Inc.
Chemistry · 262d
Cleared Jul 27, 2012
ORION
K113489 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 247d
Cleared Jul 27, 2012
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
K113544 · GZJ
Prospera Corporation
Neurology · 239d
Cleared Jul 27, 2012
EON CHOLESTEROL REAGENT
K120202 · CHH
Vital Diagnostics Pty., Ltd.
Chemistry · 186d
Cleared Jul 27, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE
K120230 · LYZ
Shandong Taixiang Medical Products...
General Hospital · 184d
Cleared Jul 27, 2012
MOJO, VERASEAL
K120463 · BZD
Sleepnet Corporation
Anesthesiology · 163d
Cleared Jul 27, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K120797 · LYZ
Shandong Shouguang Kingliyuan Medical...
General Hospital · 134d
Cleared Jul 27, 2012
ENDOBEAM HOLMIUM LASER FIBERS
K120926 · GEX
C.R. Bard, Inc.
General & Plastic Surgery · 122d
Cleared Jul 27, 2012
ZEOBI
K121338 · ILX
Ivivi Health Science, LLC
Physical Medicine · 85d
Cleared Jul 27, 2012
IPS 99 ONE AND IPS 99 CERAM
K121359 · EIH
Ivoclar Vivadent, AG
Dental · 81d
Cleared Jul 27, 2012
MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM
K121569 · ODP
Accel Spine
Orthopedic · 59d
Cleared Jul 27, 2012
ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
K121604 · FER
Obp Corporation
Gastroenterology & Urology · 56d
Cleared Jul 27, 2012
SENSICARDIAC
K121617 · DQD
Diacoustic Medical (Pty)
Cardiovascular · 56d
Cleared Jul 27, 2012
THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
K121748 · DYB
Access Scientific, Inc.
Cardiovascular · 43d
Cleared Jul 27, 2012
VEGA KNEE SYSTEM
K121879 · JWH
Aesculap Implant Systems
Orthopedic · 29d
Cleared Jul 27, 2012
PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
K121897 · KGO
Cardinal Health, Inc.
General Hospital · 28d
Cleared Jul 26, 2012
S.C.O.R.E.S. UNIT
K110898 · KCT
Ammed Surgical Equipment, LLC
General Hospital · 484d
Cleared Jul 26, 2012
A/C ENZYMATIC VITAMIN B6 ASSAY
K111260 · CDD
Anticancer, Inc.
Chemistry · 448d
Cleared Jul 26, 2012
FUJINON COLONOSCOPES
K112391 · FDF
Fujinon, Inc.
Gastroenterology & Urology · 342d
Cleared Jul 26, 2012
LDR SPINE USA AVENUE L INTERBODY FUSION
K113285 · OVD
Ldr Spine USA, Inc.
Orthopedic · 262d
Cleared Jul 26, 2012
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
K113397 · LSR
Zeus Scientific, Inc.
Microbiology · 252d
Cleared Jul 26, 2012
CAREGUIDE OXIMETER
K113656 · MUD
Reflectance Medical, Inc.
Cardiovascular · 227d
Cleared Jul 26, 2012
ORIGEN REINFORCED DUAL LUMEN CATHETER
K113869 · DWF
Origen Biomedical, Inc.
Cardiovascular · 209d