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
144025–144048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1986
MODEL KM IN-THE-CANAL HEARING AID
K862102 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UC IN-THE-CANAL HEARING AID
K862103 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UC SPECTRUM IN-THE-CANAL HEARING AID
K862104 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
LIFECARE REMOTE ALARM #34-001
K862212 · CBK
Lifecare Services, Inc.
Anesthesiology · 13d
Cleared Jun 23, 1986
SHOFU LINING CEMENT
K862280 · EMA
Shofu Dental Corp.
Dental · 7d
Cleared Jun 23, 1986
SEALITE
K862284 · EBC
Sybron Corp.
Dental · 7d
Cleared Jun 20, 1986
SDL-300
K854337 · ITX
Shimadzu Corp.
Radiology · 235d
Cleared Jun 20, 1986
PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC
K854468 · GEX
Minnesota Laser Corp.
General & Plastic Surgery · 226d
Cleared Jun 20, 1986
PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC
K854473 · GEX
Minnesota Laser Corp.
General & Plastic Surgery · 226d
Cleared Jun 20, 1986
MEDNOVA BLOOD PRESSURE CUFF
K854813 · DXQ
Mednova Corp.
Cardiovascular · 199d
Cleared Jun 20, 1986
BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT
K861499 · DAK
Biostar Medical Products, Inc.
Immunology · 58d
Cleared Jun 20, 1986
#6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL
K861903 · LNK
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 35d
Cleared Jun 20, 1986
WHITE OAK ALLERGEN DISC
K862175 · DHB
Immuno Nuclear Corp.
Immunology · 11d
Cleared Jun 20, 1986
PERSUNAL TAN, MODEL NO. HU-0208L
K862263 · FTC
Sunthetic Engineering, Inc.
General & Plastic Surgery · 7d
Cleared Jun 19, 1986
STACLOT PROTEIN C TEST KIT
K861079 · GGP
American Bioproducts Co.
Hematology · 90d
Cleared Jun 19, 1986
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY
K861372 · GEI
Snowden-Pencer
General & Plastic Surgery · 69d
Cleared Jun 19, 1986
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES
K861377 · JXG
Cordis Corp.
Neurology · 66d
Cleared Jun 19, 1986
ELECTROSURGICAL BLADE ELECTRODE (SOLID TYPE)
K861495 · GEI
National Wire & Stamping, Inc.
General & Plastic Surgery · 58d
Cleared Jun 19, 1986
PORT-A-TRAC
K861554 · JFB
Port-A-Trac Co.
Physical Medicine · 55d
Cleared Jun 19, 1986
TERUMO SENSIBEAD EIA TSH KIT
K861573 · JLW
Terumo Medical Corp.
Chemistry · 52d
Cleared Jun 19, 1986
ACUSON S228, S519 & L558 TRANSDUCERS
K861577 · HGL
Acuson Computed Sonography
Obstetrics & Gynecology · 52d
Cleared Jun 19, 1986
ELECTROSURGICAL NEEDLE ELECTRODE (SOLID TYPE)
K861594 · GEI
National Wire & Stamping, Inc.
General & Plastic Surgery · 51d
Cleared Jun 19, 1986
BALL ELECTRODES
K861595 · GEI
National Wire & Stamping, Inc.
General & Plastic Surgery · 51d
Cleared Jun 19, 1986
WISE IRIDOTOMY-SPINCTEROTOMY LENS
K861648 · HJK
Ocular Instruments, Inc.
Ophthalmic · 50d