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
72241–72264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 2003
INTRAOS 70
K031118 · EHD
Blue X Imaging Srl
Radiology · 91d
Cleared Jul 08, 2003
SEZ SAFETY SYRINGE
K031163 · MEG
Sez Corporation
General Hospital · 85d
Cleared Jul 08, 2003
CYNOSURE PHOTOLIGHT PL
K031258 · GEX
Cynosure, Inc.
General & Plastic Surgery · 78d
Cleared Jul 08, 2003
TERUMO SURGUARD 2 SAFETY NEEDLE
K031453 · FMI
Terumo Medical Corp.
General Hospital · 62d
Cleared Jul 08, 2003
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
K031555 · LXC
Synthes (Usa)
Orthopedic · 50d
Cleared Jul 08, 2003
CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)
K031690 · GEX
Cynosure, Inc.
General & Plastic Surgery · 36d
Cleared Jul 08, 2003
5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
K031929 · LLZ
Wide Corporation
Radiology · 15d
Cleared Jul 07, 2003
RESPIRATORY HUMIDIFIER, MODEL MR850
K020332 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 522d
Cleared Jul 07, 2003
FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM
K024204 · GEX
Fotona D.D.
General & Plastic Surgery · 199d
Cleared Jul 07, 2003
PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM
K030076 · JKA
Biomed Personal Metabolic and...
Chemistry · 180d
Cleared Jul 07, 2003
VENTLAB BACTERIAL FILTER, MODEL BF100
K030271 · CAH
Ventlab Corp.
General Hospital · 161d
Cleared Jul 07, 2003
NXSTAGE SYSTEM ONE
K030470 · FII
Nxstage Medical, Inc.
Gastroenterology & Urology · 145d
Cleared Jul 07, 2003
ITI DENTAL IMPLANT SYSTEM
K031055 · DZE
Straumann USA
Dental · 95d
Cleared Jul 07, 2003
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
K031208 · MSV
Corgenix, Inc.
Immunology · 81d
Cleared Jul 07, 2003
MODEL 780
K031383 · BTT
Hudson Respiratory Care, Inc.
Anesthesiology · 67d
Cleared Jul 07, 2003
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031777 · FGE
Cordis Corp.
Gastroenterology & Urology · 27d
Cleared Jul 07, 2003
DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136,...
K031905 · FLL
Actherm, Inc.
General Hospital · 17d
Cleared Jul 03, 2003
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY...
K024303 · FGE
Edwards Lifesciences, LLC
Gastroenterology & Urology · 191d
Cleared Jul 03, 2003
GENERAL SEMEN ANALYSIS (GSA) KIT
K024337 · POV
Bioshaf , Ltd.
Hematology · 188d
Cleared Jul 03, 2003
FASTPACK FREE T4 IMMUNOASSAY
K030329 · CEC
Qualigen, Inc.
Chemistry · 153d
Cleared Jul 03, 2003
SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND...
K030919 · NLR
Medisiss
Gastroenterology & Urology · 101d
Cleared Jul 03, 2003
CARBON FIBER BRIDGE, MODEL 28757
K031070 · EBI
Nobel Biocare AB
Dental · 90d
Cleared Jul 03, 2003
SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL...
K031133 · GEI
Surgrx, Inc.
General & Plastic Surgery · 85d
Cleared Jul 03, 2003
SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION
K031193 · LPN
Alcon, Inc.
Ophthalmic · 78d