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
81313–81336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2000
MILLENNIUM BLADES, MODEL MB101
K003143 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 62d
Cleared Dec 11, 2000
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
K994146 · LWJ
Plus Orthopedics
Orthopedic · 369d
Cleared Dec 10, 2000
SNARE,FLEXIBLE
K002927 · FDI
Odon Lifetechnology
Gastroenterology & Urology · 81d
Cleared Dec 08, 2000
LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
K000594 · JEY
Stryker Leibinger
Dental · 290d
Cleared Dec 08, 2000
HANGER CRANIAL BAND
K001669 · MVA
Hanger Orthopedic Group, Inc.
Neurology · 191d
Cleared Dec 08, 2000
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 170d
Cleared Dec 08, 2000
NOVOFINE 31 DISPOSABLE NEEDLE
K002403 · FMI
Novo Norodisk Pharmaceuticals, Inc.
General Hospital · 123d
Cleared Dec 08, 2000
ADVENT IMPLANT SYSTEM
K002614 · DZE
Core-Vent Corp.
Dental · 108d
Cleared Dec 08, 2000
COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE
K002691 · KKX
Com-Med International, Inc.
General Hospital · 101d
Cleared Dec 08, 2000
COOL-TEC ELECTRODES
K002841 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 87d
Cleared Dec 08, 2000
PAFLUFOCON C AND E DAILY CONTACT LENS
K002845 · HQD
Paragon Vision Sciences
Ophthalmic · 87d
Cleared Dec 08, 2000
BARD ALL-SILICONE 3-WAY FOLEY CATHETER
K002868 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 86d
Cleared Dec 08, 2000
MAGELLAN VENTILATOR
K002951 · CBK
Oceanic Medical Products, Inc.
Anesthesiology · 78d
Cleared Dec 08, 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
K002969 · GWF
Xltek
Neurology · 77d
Cleared Dec 08, 2000
STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123
K003002 · JOJ
Steritec Products, Inc.
General Hospital · 73d
Cleared Dec 08, 2000
TISSUELINK BIPOLAR FORCEPS
K003005 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 73d
Cleared Dec 08, 2000
VASCULAR CLOSURE DEVICE
K003169 · GDW
Std Mfg., Inc.
General & Plastic Surgery · 59d
Cleared Dec 08, 2000
THERMAGE THERMACOOL II SYSTEM
K003183 · GEI
Thermage, Inc.
General & Plastic Surgery · 58d
Cleared Dec 08, 2000
OPUS ROD FIXATION SYSTEM
K003490 · MNH
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Dec 08, 2000
NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP,...
K003674 · GEI
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 9d
Cleared Dec 08, 2000
SW ULTRASOUND, MODELS 331, 311, 333
K991613 · IMI
Starbene
Physical Medicine · 578d
Cleared Dec 07, 2000
TCM400
K001866 · LPP
Radiometer Medical A/S
Anesthesiology · 170d
Cleared Dec 07, 2000
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
K002481 · LDF
Zcv ,Inc.
Cardiovascular · 115d
Cleared Dec 07, 2000
DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
K003448 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 31d