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

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176,076 results
58105–58128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2007
THE LIFE VESSEL
K070690 · ILY
Cottonwood Vessel Corporation
Physical Medicine · 248d
Cleared Nov 16, 2007
FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
K071127 · HIH
Vision-Sciences, Inc.
Obstetrics & Gynecology · 207d
Cleared Nov 16, 2007
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K071161 · DZE
Southern Implants, Inc.
Dental · 204d
Cleared Nov 16, 2007
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P...
K071921 · NKB
Innovasis, Inc.
Orthopedic · 127d
Cleared Nov 16, 2007
LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC...
K072048 · ILY
Lynton Lasers Limited
Physical Medicine · 114d
Cleared Nov 16, 2007
BIOELAST 5-0 SUTURE, MODEL 500100
K072470 · NWJ
Entrigue Surgical, Inc.
General & Plastic Surgery · 73d
Cleared Nov 16, 2007
ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI...
K072483 · NHA
Atlantis Components, Inc.
Dental · 73d
Cleared Nov 16, 2007
THERMOFORM SHEET MATERIALS AND ACCESSORIES
K072522 · MQC
Dentsply International, Inc.
Dental · 70d
Cleared Nov 16, 2007
DUO TEMP
K072604 · EMA
Coltene/Whaledent AG
Dental · 60d
Cleared Nov 16, 2007
CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US
K072643 · KZN
Olympus Corporation
Dental · 59d
Cleared Nov 16, 2007
VITEK 2 GRAM POSITIVE TIGECYCLINE
K072695 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Nov 16, 2007
CONFIDANT 2.5
K072698 · DRG
Confidant, Inc.
Cardiovascular · 53d
Cleared Nov 16, 2007
GALEMED CPAP MASK
K072755 · BZD
Galemed Corp.
Anesthesiology · 50d
Cleared Nov 16, 2007
LBS-63-16 BREAST ARRAY COIL
K072873 · MOS
Invivo
Radiology · 38d
Cleared Nov 16, 2007
LBS-127-16 BREAST ARRAY COIL
K072874 · MOS
Invivo
Radiology · 38d
Cleared Nov 16, 2007
SOPRO 225 DUAL HALOGEN LIGHT SOURCE
K072912 · GCJ
Sopro
General & Plastic Surgery · 35d
Cleared Nov 16, 2007
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
K072946 · EGJ
Empi
Physical Medicine · 30d
Cleared Nov 16, 2007
GE ECHOPAC
K072952 · LLZ
General Electric Co.
Radiology · 29d
Cleared Nov 16, 2007
PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS
K073032 · NHA
Lifecore Biomedical, Inc.
Dental · 21d
Cleared Nov 16, 2007
SKINTACT AND VARIOUS OTHER TRADENAMES
K073104 · DRX
Leonhard Lang GmbH
Cardiovascular · 14d
Cleared Nov 16, 2007
COLLIMARE COLLIMATOR FAMILY
K073124 · IZW
Collimare, LLC
Radiology · 10d
Cleared Nov 16, 2007
INTERSTITIAL NEEDLES
K073133 · JAQ
Varian Medical Systems, Inc.
Radiology · 9d
Cleared Nov 16, 2007
A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I
K073134 · ITI
Invacare Corporation
Physical Medicine · 9d
Cleared Nov 16, 2007
DRAD-3000E, RADREX-I
K073165 · MQB
Toshiba America Medical Systems, In.C
Radiology · 7d