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
68545–68568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2004
PERIOLASE ND:YAG DENTAL LASER SYSTEM
K030290 · GEX
Millennium Dental Technologies, Inc.
General & Plastic Surgery · 550d
Cleared Jul 26, 2004
ECLIPSE WITH AAA
K041403 · MUJ
Varian Medical Systems
Radiology · 61d
Cleared Jul 26, 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K041420 · LJS
AngioDynamics, Inc.
General Hospital · 59d
Cleared Jul 26, 2004
PANORAMA 1.0T
K041602 · LNH
Philips Medical Systems North...
Radiology · 42d
Cleared Jul 26, 2004
GE SIGNA PROFILE 6 INCH GP COIL
K041921 · MOS
Ge Medical Systems, LLC
Radiology · 10d
Cleared Jul 23, 2004
TRIMED PLAN, VERSION 2.2
K031088 · MUJ
Trimed Systems, Inc.
Radiology · 476d
Cleared Jul 23, 2004
EXTENTRAC ELITE
K031996 · ITH
Advanced Back Technologies
Physical Medicine · 392d
Cleared Jul 23, 2004
SILVERSEAL
K040019 · MGQ
Noble Fiber Technologies
General & Plastic Surgery · 199d
Cleared Jul 23, 2004
EQUESTRA FLUID DELIVERY SYSTEM
K040483 · HRX
Medtronic Sofamor Danek, Inc.
Orthopedic · 149d
Cleared Jul 23, 2004
AMERICAN BANTEX MS 4 MINI SCOOTER
K040754 · INI
American Bantex Corp.
Physical Medicine · 121d
Cleared Jul 23, 2004
LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
K040844 · KWQ
Life Spine, LLC
Orthopedic · 113d
Cleared Jul 23, 2004
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
K040913 · MXK
Bausch & Lomb
Ophthalmic · 106d
Cleared Jul 23, 2004
ELEKTA MICRODRIVE, MODEL 916716
K040979 · HAW
Elekta Instrument AB
Neurology · 99d
Cleared Jul 23, 2004
STRAUMANN TEMPORARY COPING
K041070 · NHA
The Straumann Co.
Dental · 88d
Cleared Jul 23, 2004
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
K041138 · LPL
CooperVision, Inc.
Ophthalmic · 84d
Cleared Jul 23, 2004
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K041167 · NKB
Pioneer Surgical Technology
Orthopedic · 80d
Cleared Jul 23, 2004
NOBELRONDO DENTAL CERAMIC-ALUMINA
K041312 · EIH
Nobel Biocare Uas, Inc.
Dental · 67d
Cleared Jul 23, 2004
SINON SN-L402 LIGHTWEIGHT WHEELCHAIR
K041465 · IOR
Sinon Corporation
Physical Medicine · 51d
Cleared Jul 23, 2004
XPS 3000 SYSTEM
K041523 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 45d
Cleared Jul 23, 2004
L1-PRO SYSTEM
K041665 · FMK
Pelikan Technologies, Inc.
General & Plastic Surgery · 35d
Cleared Jul 23, 2004
PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS
K041675 · IYN
Pie Medical
Radiology · 32d
Cleared Jul 23, 2004
KARMA POWER WHEELCHAIR, MODEL KP-25
K041678 · ITI
Karma Medical Products Co., Ltd.
Physical Medicine · 32d
Cleared Jul 23, 2004
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K041695 · LNH
Usa Instruments, Inc.
Radiology · 31d
Cleared Jul 23, 2004
HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER,...
K041726 · KDI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 28d