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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
46465–46488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2011
JOURNEY II BCS KNEE SYSTEM
K111711 · JWH
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Sep 16, 2011
AVIAFIT
K111720 · JOW
Flowmedic , Ltd.
Cardiovascular · 88d
Cleared Sep 16, 2011
EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD...
K111728 · CGA
Eps Bio Technology Corp.
Chemistry · 88d
Cleared Sep 16, 2011
BEAUTISEALANT
K111782 · EBC
Shofu Dental Corporation
Dental · 84d
Cleared Sep 16, 2011
PERMASHADE VENEER CEMENT
K111836 · EMA
Ultradent Products, Inc.
Dental · 79d
Cleared Sep 16, 2011
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K112067 · FRN
Carticept Medical, Inc.
General Hospital · 59d
Cleared Sep 16, 2011
S8 DIAGNOSTIC ULTRASOUND SYSTEM
K112451 · IYN
Sonoscape Company Limited
Radiology · 22d
Cleared Sep 16, 2011
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K112596 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 9d
Cleared Sep 15, 2011
R4 ACERT ULTRASOUND REPORTING SYSTEM
K101898 · LLZ
R4, LLC
Radiology · 435d
Cleared Sep 15, 2011
GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
K102816 · NBW
Apex BioTechnology Corp.
Chemistry · 352d
Cleared Sep 15, 2011
SEVEN IMPLANTS
K103089 · DZE
Mis - Implant Technologies , Ltd.
Dental · 331d
Cleared Sep 15, 2011
EQUAL DOSE
K103515 · MUJ
Nucletron Corporation
Radiology · 289d
Cleared Sep 15, 2011
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR...
K103639 · CAP
Vortran Medical Technology 1, Inc.
Anesthesiology · 276d
Cleared Sep 15, 2011
FEEL-DRCS
K110033 · LLZ
Imfou Co., Ltd.
Radiology · 253d
Cleared Sep 15, 2011
Q-CLEAR
K110370 · PDZ
Light Age, Inc.
General & Plastic Surgery · 219d
Cleared Sep 15, 2011
KOLPLUX SYSTEM
K110766 · HIB
Kolplast CI Ltda
Obstetrics & Gynecology · 181d
Cleared Sep 15, 2011
BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL
K111003 · DZE
Biodenta Swiss AG
Dental · 157d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111457 · NKB
Medtronic Sofamor Danek
Orthopedic · 112d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111510 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 106d
Cleared Sep 15, 2011
ASTRA
K111694 · LLZ
Candelis, Inc.
Radiology · 91d
Cleared Sep 15, 2011
MOLECULAR BREAST IMAGING SOFTWARE
K111731 · LLZ
Gamma Medica-Ideas Incorporated
Radiology · 87d
Cleared Sep 15, 2011
PATHASSIST LIGHT FIBER
K111763 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 84d
Cleared Sep 15, 2011
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
K111767 · GZI
Ness-Neuromuscular Electrical...
Neurology · 84d
Cleared Sep 15, 2011
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
K111966 · LPL
CooperVision, Inc.
Ophthalmic · 66d