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
63865–63888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2006
FLOWHANDY ZAN100 USB
K052176 · BZG
Zan Messgerate GmbH
Anesthesiology · 155d
Cleared Jan 12, 2006
DELTA4
K052920 · IYE
Scandidos AB
Radiology · 87d
Cleared Jan 12, 2006
ALARIS SAFETY MALE LUER
K053049 · FPA
Cardinal Health, Alaris Products
General Hospital · 76d
Cleared Jan 12, 2006
LOFLO C5 CO2 SENSOR
K053174 · CCK
Respironics Novametrix, LLC
Anesthesiology · 59d
Cleared Jan 12, 2006
CDMX-H
K053221 · MUH
Camsight Co., Inc.
Radiology · 56d
Cleared Jan 12, 2006
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET
K053283 · CAZ
Pajunk GmbH
Anesthesiology · 48d
Cleared Jan 11, 2006
6248VAL ADJUSTABLE VALVE
K052459 · DTL
Medtronic Vascular
Cardiovascular · 126d
Cleared Jan 11, 2006
SIMPLICI-T ANNULOPLASTY SYSTEM
K052970 · KRH
Medtronic Heart Valves
Cardiovascular · 79d
Cleared Jan 11, 2006
POWDERED VINYL EXAMINATION GLOVE
K052984 · LYZ
Tg Medical (China) Incorporation
General Hospital · 79d
Cleared Jan 11, 2006
ONYX II FINGER PULSE OXIMETER, MODEL 9550
K053130 · DQA
Nonin Medical, Inc.
Anesthesiology · 64d
Cleared Jan 11, 2006
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K053472 · KTT
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Jan 10, 2006
OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR
K051271 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 238d
Cleared Jan 10, 2006
EXFEEL IMPLANT SYSTEM
K052369 · DZE
Megagen Co., Ltd.
Dental · 134d
Cleared Jan 10, 2006
TEGO, MODEL D1000
K053106 · FPA
Icu Medical, Inc.
General Hospital · 67d
Cleared Jan 10, 2006
PRECISION BLENDER
K053232 · BZR
Precision Medical, Inc.
Anesthesiology · 53d
Cleared Jan 10, 2006
NEWPORT E360 VENTILATOR
K053502 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 25d
Cleared Jan 10, 2006
PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS,...
K053522 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 22d
Cleared Jan 09, 2006
CG-7000DX-BT ECG RECORDER/TRANSMITTER
K052556 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 115d
Cleared Jan 09, 2006
PARAPOST PARACORE AUTOMIX 5ML
K052820 · EBF
Coltene/Whaledent AG
Dental · 97d
Cleared Jan 09, 2006
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
K053425 · HLJ
Precision Optics Corp.
Ophthalmic · 32d
Cleared Jan 06, 2006
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
K051031 · FIN
Ameriwater
Gastroenterology & Urology · 259d
Cleared Jan 06, 2006
UROK ROCKING WHEELCHAIR, MODEL 700-4XX
K052548 · IOR
Amg Medical, Inc.
Physical Medicine · 112d
Cleared Jan 06, 2006
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113,...
K052566 · MNI
Abbott Spine, Inc.
Orthopedic · 109d
Cleared Jan 06, 2006
THE FINGER GUARD
K052619 · DQA
T F & G Products
Anesthesiology · 105d