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
51049–51072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2010
DIGITAL ULTRASOUND SCANNER
K100079 · IYO
Shenzhen Well.D Medical Electronics...
Radiology · 48d
Cleared Mar 01, 2010
DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32
K100386 · GDW
Changzhou Waston Medical Appliance...
General & Plastic Surgery · 13d
Cleared Feb 26, 2010
SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT
K083876 · NHA
Cendres & Metaux SA
Dental · 424d
Cleared Feb 26, 2010
ASAHI ZENYTEEX GUIDING CATHETER
K091188 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 309d
Cleared Feb 26, 2010
PYTON
K092733 · BSK
Arm Medical Devices, Inc.
Anesthesiology · 175d
Cleared Feb 26, 2010
TELESENTRY, MODEL TS01
K092947 · DSI
Scottcare Corporation
Cardiovascular · 155d
Cleared Feb 26, 2010
TRAILRUNNER GUIDEWIRES
K092965 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 154d
Cleared Feb 26, 2010
SPIROPALM
K093174 · BZG
Cosmed Srl
Anesthesiology · 141d
Cleared Feb 26, 2010
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831,...
K093203 · GEI
Medtronic, Inc.
General & Plastic Surgery · 136d
Cleared Feb 26, 2010
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
K093209 · BSP
Cook, Inc.
Anesthesiology · 136d
Cleared Feb 26, 2010
AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
K093463 · NDN
Care Fusion
Orthopedic · 112d
Cleared Feb 26, 2010
EASYCARE ONLINE
K093684 · BZD
Resmed, Ltd.
Anesthesiology · 88d
Cleared Feb 26, 2010
ASEPT PERITONEAL DRAINAGE SYSTEM
K093796 · PNG
Pfm Medical, Inc.
Gastroenterology & Urology · 77d
Cleared Feb 26, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K100074 · LYZ
Tangshan Jiteng Plastic Products Co.,...
General Hospital · 46d
Cleared Feb 26, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
K100075 · LYZ
Tangshan Jiteng Plastic Products Co.,...
General Hospital · 46d
Cleared Feb 26, 2010
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
K100282 · FOZ
Terumo Corp.
General Hospital · 25d
Cleared Feb 25, 2010
ITG VASCULAR ACCESS SYSTEM, MODEL 300
K091006 · DYB
Arstasis, Inc.
Cardiovascular · 323d
Cleared Feb 25, 2010
BINDER INTERVERTEBRAL BODY FUSION DEVICE
K093015 · MAX
Binder Biomedical, Inc.
Orthopedic · 149d
Cleared Feb 25, 2010
ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM,...
K093592 · NBW
Taidoc Technology Corporation
Chemistry · 98d
Cleared Feb 25, 2010
SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC...
K093741 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 83d
Cleared Feb 25, 2010
ENSITE VELOCITY SYSTEM V1.3
K093942 · DQK
St Jude Medical
Cardiovascular · 65d
Cleared Feb 25, 2010
VISION SCIENCES FLEXIBLE ENT SCOPE
K100125 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 37d
Cleared Feb 24, 2010
STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS
K090068 · FRG
Case Medical, Inc.
General Hospital · 411d
Cleared Feb 24, 2010
LUBREASE FEMALE LUBRICANT
K091298 · NUC
Curves Limited
Obstetrics & Gynecology · 296d