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
60121–60144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2007
STRYKER FOOT PLATING SYSTEM
K063875 · HRS
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared Mar 15, 2007
GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
K070048 · FCM
Marian Medical, Inc.
Gastroenterology & Urology · 71d
Cleared Mar 15, 2007
NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES
K070072 · LYY
Medtexx Manufacturing Sdn. Bhd.
General Hospital · 66d
Cleared Mar 15, 2007
SECURE ARTERIAL BLOOD SAMPLING SYSTEM
K070340 · CBT
Smiths Medical Asd, Inc.
Anesthesiology · 37d
Cleared Mar 15, 2007
CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
K070448 · NQH
Cardiomems, Inc.
Cardiovascular · 28d
Cleared Mar 15, 2007
CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD...
K070472 · NBW
Taidoc Technology Corporation
Chemistry · 23d
Cleared Mar 15, 2007
EXACTECH NOVATION CROWN CUP AND LINERS
K070479 · LZO
Exactech, Inc.
Orthopedic · 23d
Cleared Mar 15, 2007
ADVACOAT SINUS GEL AND STENT
K070496 · LYA
Carbylan Biosurgery
Ear, Nose, Throat · 23d
Cleared Mar 15, 2007
MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
K070522 · MJH
Inverness Medical Professional...
Microbiology · 20d
Cleared Mar 15, 2007
MORTARA ELI 10 ELECTROCARDIOGRAPH
K070539 · DPS
Mortara Instrument, Inc.
Cardiovascular · 17d
Cleared Mar 14, 2007
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
K061881 · JEY
Takiron Co., Ltd.
Dental · 254d
Cleared Mar 14, 2007
TINA-QUANT D-DIMER TEST SYSTEM
K062203 · GHH
Roche Diagnostics Corp.
Hematology · 225d
Cleared Mar 14, 2007
MODIFICATION TO S4 SPINAL SYSTEM
K062327 · NKB
Aesculap, Inc.
Orthopedic · 216d
Cleared Mar 14, 2007
JOYKEY SURGICAL GOWNS (STERILE)
K062479 · FYA
Joykey Industryial , Ltd.
General Hospital · 202d
Cleared Mar 14, 2007
CONCEIVEX CONCEPTION KIT
K063227 · OBB
Conceivex, Inc.
Obstetrics & Gynecology · 141d
Cleared Mar 14, 2007
CTBOX CERVICAL/LUMBAR TRACTION
K063353 · ITH
Circular Traction Supply, Inc.
Physical Medicine · 128d
Cleared Mar 14, 2007
ALPHA BIO DENTAL IMPLANT SYSTEM
K063364 · DZE
Alpha-Bio Tec , Ltd.
Dental · 127d
Cleared Mar 14, 2007
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
K063775 · MST
Phadia US, Inc.
Immunology · 83d
Cleared Mar 14, 2007
SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA
K063859 · GCJ
Surgiquest, Inc.
General & Plastic Surgery · 76d
Cleared Mar 14, 2007
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR
K070096 · LZA
Gx Corporation Sdn Bhd
General Hospital · 63d
Cleared Mar 14, 2007
VERTE-STACK SPINAL SYSTEM
K070173 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 55d
Cleared Mar 14, 2007
ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K070262 · JTN
Oxoid , Ltd.
Microbiology · 47d
Cleared Mar 14, 2007
MODIFICATION TO HYPERTRANSIT INFUSION CATHETER
K070279 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 44d
Cleared Mar 14, 2007
P&F POWER WHEELCHAIR, HC-510
K070350 · ITI
P & F Brother Ind., Corp.
Physical Medicine · 36d