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
76393–76416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 2002
ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
K020383 · JWH
Ortho Development Corp.
Orthopedic · 90d
Cleared May 06, 2002
T2 ARTHRODESIS NAIL SYSTEM
K020384 · HSB
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared May 06, 2002
SPIFE 2000/3000 ALP 40, 20
K020625 · CIN
Helena Laboratories
Chemistry · 69d
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
K020627 · LTT
Dade Microscan, Inc.
Microbiology · 69d
Cleared May 06, 2002
INRATIO
K020679 · GJS
Hemosense, Inc.
Hematology · 63d
Cleared May 06, 2002
RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG...
K020716 · DJG
Rapid Diagnostics, Inc.
Toxicology · 62d
Cleared May 06, 2002
WET CHAMBER
K020781 · NAD
Kinetic Concepts, Inc.
General & Plastic Surgery · 56d
Cleared May 06, 2002
SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K020917 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 46d
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
K020937 · JWY
Dade Microscan, Inc.
Microbiology · 45d
Cleared May 06, 2002
MICROSTREP PLUS PANEL WITH AMPICILLIN
K021037 · JWY
Dade Behring, Inc.
Microbiology · 35d
Cleared May 03, 2002
PSYCHEMEDICS RIA CANNABINOID ASSAY
K011426 · LAT
Psychemedics Corp.
Toxicology · 360d
Cleared May 03, 2002
INDWELLING FECAL MANAGEMENT SYSTEM
K012113 · KNT
Bowel Management Systems, LLC
Gastroenterology & Urology · 301d
Cleared May 03, 2002
SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
K012800 · HRY
Whiteside Biomechanics, Inc.
Orthopedic · 255d
Cleared May 03, 2002
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
K014068 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 144d
Cleared May 03, 2002
SANIDAD HEALTH-UP TENS MP-73725
K014126 · GZJ
Roc Chinese-European Industrial...
Neurology · 137d
Cleared May 03, 2002
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230...
K020354 · GXD
Baylis Medical Co., Inc.
Neurology · 88d
Cleared May 03, 2002
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
K020365 · KRI
3t Medical Systems, LLC
Cardiovascular · 88d
Cleared May 03, 2002
OCULIGHT SL/SLX
K020374 · HQF
Iridex Corp
Ophthalmic · 88d
Cleared May 03, 2002
THE NURTURE III BREAST PUMP
K020375 · HGX
Bailey Medical Engineering
Obstetrics & Gynecology · 88d
Cleared May 03, 2002
MASTER & FRANK SURGICAL DRAPES (STERILE)
K020393 · KKX
Master & Frank Enterprses Co., Ltd.
General Hospital · 86d
Cleared May 03, 2002
MEDION 6000
K020476 · EGJ
Selectivemed Components, Inc.
Physical Medicine · 80d
Cleared May 03, 2002
SMOKE EVACUATION HOSES/TUBING
K020510 · FYD
Dm Medical, Inc.
General Hospital · 77d
Cleared May 03, 2002
MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
K020554 · JWJ
Kinetikos Medical, Inc.
Orthopedic · 72d
Cleared May 03, 2002
STARFLOW HV
K020760 · EBF
Danville Materials, Inc.
Dental · 57d