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
61129–61152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2006
C-PORT DISTAL ANASTOMOSIS SYSTEM
K053524 · FZP
Cardica, Inc.
General & Plastic Surgery · 332d
Cleared Nov 16, 2006
HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER
K061933 · FMI
Hager Worldwide, Inc.
General Hospital · 132d
Cleared Nov 16, 2006
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1...
K062123 · DIO
Ortho-Clinical Diagnostics, Inc.
Chemistry · 114d
Cleared Nov 16, 2006
IMPRESSIX, COLORCHANGE ALGINATE
K062400 · ELW
Cavex Holland BV
Dental · 92d
Cleared Nov 16, 2006
KINETIC ANTERIOR CERVICAL PLATE
K062643 · KWQ
Life Spine
Orthopedic · 71d
Cleared Nov 16, 2006
SIERRA
K062934 · MNI
Seaspine, Inc.
Orthopedic · 49d
Cleared Nov 16, 2006
2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC
K063289 · LLZ
Chi Lin Technology Co., Ltd.
Radiology · 15d
Cleared Nov 15, 2006
TENACORE SP02 SENSORS
K053420 · DQA
Tenacore Holdings, Inc.
Anesthesiology · 342d
Cleared Nov 15, 2006
MAXIMA ANTERIOR CERVICAL PLATE SYSTEM
K061002 · KWQ
U&I Corp.
Orthopedic · 218d
Cleared Nov 15, 2006
RIVA LUTING PLUS
K062065 · EMA
Southern Dental Industries, Inc.
Dental · 118d
Cleared Nov 15, 2006
TRIDENT LARGE DIAMETER ACETABULAR INSERTS
K062419 · LPH
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Nov 15, 2006
ELI 350 ELECTROCARDIOGRAPH
K062677 · DPS
Mortara Instrument, Inc.
Cardiovascular · 68d
Cleared Nov 15, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML
K062944 · LON
Becton, Dickinson & CO
Microbiology · 48d
Cleared Nov 15, 2006
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
K063302 · EIA
Shanghai Dental Instrument Factory
Dental · 14d
Cleared Nov 14, 2006
IRIDEX WIRELESS FOOTSWITCH
K062074 · HQF
Iridex Corp
Ophthalmic · 116d
Cleared Nov 14, 2006
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC...
K062262 · LPL
Ciba Vision Corporation
Ophthalmic · 102d
Cleared Nov 14, 2006
IMAX CEPH DIGITAL X-RAY SENSOR
K062403 · MUH
Owandy
Radiology · 89d
Cleared Nov 14, 2006
BARRX HALO COAGULATION SYSTEM
K062441 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 85d
Cleared Nov 14, 2006
DENLASER 800 PLUS
K062619 · GEX
CAO Group, Inc.
General & Plastic Surgery · 70d
Cleared Nov 14, 2006
LUMACARE LC-122M NON-COHERENT LIGHT SOURCE
K062871 · GEX
Lynton Lasers Limited
General & Plastic Surgery · 50d
Cleared Nov 14, 2006
MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM
K063085 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Nov 14, 2006
SYNTHES ANTEGRA SYSTEM
K063158 · KWQ
Synthes Spine Co.Lp
Orthopedic · 28d
Cleared Nov 14, 2006
SPIDERFX EMBOLIC PROTECTION DEVICE
K063204 · NTE
Ev3, Inc.
Cardiovascular · 22d
Cleared Nov 14, 2006
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004
K063222 · QYX
Cardionet, Inc.
Cardiovascular · 21d