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

Filters: Cleared only ×
175,820 results
32929–32952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2016
ArcScan Insight 100
K153416 · IYO
Arcscan, Inc.
Radiology · 69d
Cleared Feb 02, 2016
WS80A Diagnostic Ultrasound System
K153529 · IYN
Samsung Medison Co., Ltd.
Radiology · 55d
Cleared Feb 02, 2016
iHealth Track Blood Pressure Monitor
K160014 · DXN
Andon Health Co, Ltd.
Cardiovascular · 29d
Cleared Feb 01, 2016
Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic...
K151036 · GCJ
Carefusion 2200, Inc.
General & Plastic Surgery · 287d
Cleared Feb 01, 2016
YAHUA Spinal System
K152324 · MNI
Beijing Weigao Yahua Artificial Joint...
Orthopedic · 168d
Cleared Feb 01, 2016
C2 NerveMonitor System
K152505 · ETN
Inomed Medizintechnik GmbH
Ear, Nose, Throat · 152d
Cleared Feb 01, 2016
In2Bones Kirschner wire
K153204 · HTY
In2bones Sas
Orthopedic · 89d
Cleared Feb 01, 2016
Hansen Medical Magellan Robotic Catheter eKit
K153304 · DRA
Hansen Medical, Inc.
Cardiovascular · 77d
Cleared Feb 01, 2016
PacEndo EDTA
K153528 · KJJ
Pac-Dent International, Inc.
Dental · 54d
Cleared Feb 01, 2016
Image1 SPIES System
K160044 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 24d
Cleared Jan 31, 2016
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme...
K143470 · GIS
Diazyme Laboratories
Hematology · 422d
Cleared Jan 30, 2016
ROSC-U Mini Chest Compressor (RMCC)
K153628 · DRM
Resuscitation International, LLC
Cardiovascular · 43d
Cleared Jan 29, 2016
URight Hemoglobin A1c system, FORA A1c System
K142664 · LCP
Taidoc Technology Corporation
Chemistry · 498d
Cleared Jan 29, 2016
IntelliCuff
K150893 · BSK
Hamilton Medical AG
Anesthesiology · 302d
Cleared Jan 29, 2016
KLOCKNER DENTAL IMPLANT ABUTMENTS (II)
K151194 · NHA
SOADCO, S.L.
Dental · 270d
Cleared Jan 29, 2016
ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+
K151426 · IYE
Scandidos AB
Radiology · 246d
Cleared Jan 29, 2016
TriMed Humeral Supracondylar Fixation System
K151735 · HRS
TriMed, Inc.
Orthopedic · 217d
Cleared Jan 29, 2016
COALITION Spacers
K151939 · OVE
Globus Medical, Inc.
Orthopedic · 199d
Cleared Jan 29, 2016
ATLANTIS Crown
K152247 · EIH
Dentsply International, Inc.
Dental · 172d
Cleared Jan 29, 2016
EYE-SYNC
K152915 · GWN
Syncthink, Inc.
Neurology · 119d
Cleared Jan 29, 2016
Sonendo Gentle Wave System
K153157 · ELC
Sonendo, Inc.
Dental · 88d
Cleared Jan 29, 2016
PASS OCT Patient Specific Rods
K153169 · NKG
Medicrea International
Orthopedic · 88d
Cleared Jan 29, 2016
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
K153428 · NKB
Orthofix, Inc.
Orthopedic · 65d
Cleared Jan 29, 2016
SD5 & SD6 Ultrasonic Tabletop Doppler
K153475 · KNG
Edan Instruments, Inc.
Radiology · 58d