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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
79345–79368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2001
SCS DT-02 TRANSVERSE CONNECTOR
K003823 · KWP
Ortho Tec, LLC
Orthopedic · 212d
Cleared Jul 11, 2001
SIGN IM NAIL
K011129 · HSB
Sign, Inc.
Orthopedic · 89d
Cleared Jul 11, 2001
TELEPAX
K011173 · LLZ
Imed Systems & Consulting, LLC
Radiology · 85d
Cleared Jul 11, 2001
DEVILBISS 9000 SERIES CPAP, MODEL 9001
K011229 · BZD
Sunrise Medical Hhg, Inc.
Anesthesiology · 79d
Cleared Jul 11, 2001
RECTOSIGHT RS300-04
K011825 · FER
Sightline Technologies , Ltd.
Gastroenterology & Urology · 30d
Cleared Jul 11, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K011851 · DQA
Masimo Corp.
Anesthesiology · 28d
Cleared Jul 11, 2001
MODIFIED M-IV MAMMOGRAPHY SYSTEM
K011987 · IZH
Lorad, A Hologic Co.
Radiology · 15d
Cleared Jul 10, 2001
POWDER FREE LATEX EXAMINATION GLOVES
K010546 · LYY
Jb Star Sdn Bhd
General Hospital · 137d
Cleared Jul 10, 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
K010748 · LCP
Beckman Coulter, Inc.
Hematology · 119d
Cleared Jul 10, 2001
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
K011138 · HRY
Biomet, Inc.
Orthopedic · 88d
Cleared Jul 10, 2001
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
K011205 · KXK
Isoaid
Radiology · 82d
Cleared Jul 10, 2001
EAR THERMOMETER, MODELS ST613C AND ST613F
K011254 · FLL
Mesure Technology
General Hospital · 77d
Cleared Jul 10, 2001
POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/...
K011293 · LYY
Multisafe Sdn. Bhd.
General Hospital · 71d
Cleared Jul 10, 2001
UROLOGIC
K011311 · OWB
Pck Electronic Industry and Trade Co,...
Radiology · 71d
Cleared Jul 10, 2001
SURGICAL DRAPES
K011422 · KKX
Advance Medical Designs, Inc.
General Hospital · 62d
Cleared Jul 10, 2001
CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE
K011497 · LZA
Tillotson Healthcare Corp.
General Hospital · 56d
Cleared Jul 10, 2001
LUTE
K011517 · EBF
First Scientific Limited
Dental · 54d
Cleared Jul 10, 2001
ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)
K011808 · MQX
Asia-Med GmbH and CO KG
General Hospital · 29d
Cleared Jul 10, 2001
BIS ENGINE
K011834 · OLW
Aspect Medical Systems, Inc.
Neurology · 28d
Cleared Jul 10, 2001
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K011882 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 22d
Cleared Jul 10, 2001
POWDERED BLUE NITRILE EXAMINATION GLOVES
K011924 · LZA
Seltom Pacific Sdn. Bhd.
General Hospital · 20d
Cleared Jul 10, 2001
MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX
K011997 · GCJ
Pajunk GmbH
General & Plastic Surgery · 13d
Cleared Jul 09, 2001
S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT...
K001962 · LPL
Bescon Co., Ltd.
Ophthalmic · 377d
Cleared Jul 09, 2001
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS...
K002099 · LPL
Bescon Co., Ltd.
Ophthalmic · 363d