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
140809–140832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 1987
T4012 TSB 2ML
K870595 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 48d
Cleared Mar 30, 1987
VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE
K870679 · FBO
Van-Tec, Inc.
Gastroenterology & Urology · 39d
Cleared Mar 30, 1987
VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH
K870696 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 39d
Cleared Mar 30, 1987
COSMOS
K870856 · IYB
Pausch Corp.
Radiology · 27d
Cleared Mar 30, 1987
TISSUE CULTURE BAG
K870865 · KJA
American Fluoroseal Corp.
Pathology · 27d
Cleared Mar 30, 1987
CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500
K870906 · EFW
Cost Rite Health Products, Inc.
Dental · 25d
Cleared Mar 30, 1987
HEARING AID
K870982 · ESD
Audioear Electronics
Ear, Nose, Throat · 20d
Cleared Mar 30, 1987
3M INSTANT FIT CUSTOM EARMOLD
K870985 · ESD
3M Company
Ear, Nose, Throat · 19d
Cleared Mar 30, 1987
PRICE'S ACID-FAST STAIN
K870988 · JTS
Devetec, Inc.
Pathology · 19d
Cleared Mar 27, 1987
CAPILLARY FLOW HOLLOW FIBER DIALYZERS
K863044 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 228d
Cleared Mar 27, 1987
BIOPSY NEEDLE GUIDE ATTACHMENT
K863797 · HGL
Elscint, Inc.
Obstetrics & Gynecology · 179d
Cleared Mar 27, 1987
280SL IMAGING SYSTEM TRANVAGINAL PROBES
K864151 · HGL
Ge Medical Systems Information...
Obstetrics & Gynecology · 155d
Cleared Mar 27, 1987
TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE
K864219 · HGL
Amedic USA
Obstetrics & Gynecology · 150d
Cleared Mar 27, 1987
MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR
K864261 · BZQ
Bio-Dyne, Inc.
Anesthesiology · 149d
Cleared Mar 27, 1987
ACUSON TV519 TRANSDUCER
K864578 · HGL
Acuson Computed Sonography
Obstetrics & Gynecology · 127d
Cleared Mar 27, 1987
COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS
K864831 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 108d
Cleared Mar 27, 1987
DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
K864908 · HGL
Diasonics, Inc.
Obstetrics & Gynecology · 102d
Cleared Mar 27, 1987
POWDERED BICARBONATE CONCENTRATE
K865078 · KPO
Bicarbolyte Corp.
Gastroenterology & Urology · 88d
Cleared Mar 27, 1987
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K870704 · GBX
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 35d
Cleared Mar 27, 1987
7.5 MHZ ENDOVAGINAL PROBE
K870709 · HGL
Philips Ultrasound, Inc.
Obstetrics & Gynecology · 35d
Cleared Mar 27, 1987
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701
K870728 · DRQ
A&D Engineering, Inc.
Cardiovascular · 31d
Cleared Mar 27, 1987
ADULT APNEA MONITOR (20), MONITOR INTERFACE (30)
K870835 · BZQ
Applied Membrane Technology, Inc.
Anesthesiology · 24d
Cleared Mar 27, 1987
PHARMASEAL WOUND CARE DRESSING PAD
K870941 · KOZ
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 18d
Cleared Mar 26, 1987
OMRON ULTRASONIC NEBULIZER MODEL NE-UO5
K864466 · CAF
Omron Tateisi Electronics Co.
Anesthesiology · 134d