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
47113–47136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2011
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
K111485 · DQX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jun 30, 2011
MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
K111488 · DQX
Bridgepoint Medical
Cardiovascular · 30d
Cleared Jun 30, 2011
FATHOM (TM) 14 STEERABLE GUIDEWIRE
K111498 · DQX
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jun 30, 2011
ACUSON
K111674 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Jun 29, 2011
ASICO SOFTIP INJECTOR SYSTEM
K103495 · MSS
Asico, LLC
Ophthalmic · 212d
Cleared Jun 29, 2011
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS
K110099 · LPL
CooperVision, Inc.
Ophthalmic · 167d
Cleared Jun 29, 2011
WAVEGUARD (TM) EEG CAP
K110223 · GXY
Eemagine Medical Imaging Solutions GmbH
Neurology · 155d
Cleared Jun 29, 2011
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
K110616 · JJY
Microgenics Corp.
Chemistry · 118d
Cleared Jun 29, 2011
CORIN MINIHIP FEMORAL STEM
K111046 · LZO
Corin USA
Orthopedic · 75d
Cleared Jun 29, 2011
MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER
K111672 · GEI
Pacific Hospital Supply Co., Ltd.
General & Plastic Surgery · 14d
Cleared Jun 28, 2011
PATIENT MONITOR
K101692 · MHX
Contec Medical System Co., Ltd.
Cardiovascular · 377d
Cleared Jun 28, 2011
HALIFAX BIOMEDICAL TANATLUM BEAD SET
K103417 · NEU
Halifax Biomedical, Inc.
General & Plastic Surgery · 218d
Cleared Jun 28, 2011
IVAS 2-10MM (10 GUAGE) BALLON CATHETER
K103807 · NDN
Stryker Corporation
Orthopedic · 181d
Cleared Jun 28, 2011
INDIKO
K110035 · JJE
Thermofisher Scientific OY
Chemistry · 174d
Cleared Jun 28, 2011
MEDART DIODE LASER SYSTEM & ACCESSORIES
K110243 · GEX
Medart A/S
General & Plastic Surgery · 152d
Cleared Jun 28, 2011
BIPOLAR HF DEVICE
K110695 · GEI
Aesculap, Inc.
General & Plastic Surgery · 106d
Cleared Jun 28, 2011
DRYTOUCH SUCTION STIMULATOR PROBE
K110712 · ETN
Neurovision Medical Products, Inc.
Ear, Nose, Throat · 106d
Cleared Jun 28, 2011
HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
K110752 · ITX
Highland Instruments
Radiology · 102d
Cleared Jun 28, 2011
APTUS FOOT 3.5 SYSTEM
K110908 · HRS
Medartis AG
Orthopedic · 89d
Cleared Jun 28, 2011
VITAL SERUM CONTROLS
K111063 · JJY
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 71d
Cleared Jun 28, 2011
VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304,...
K111180 · DSH
Vasomedical, Inc.
Cardiovascular · 62d
Cleared Jun 28, 2011
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
K111340 · LNH
Medtec, Inc.
Radiology · 47d
Cleared Jun 28, 2011
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
K111658 · KFM
Medtronic, Inc.
Cardiovascular · 14d
Cleared Jun 27, 2011
U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD...
K101509 · NBW
Taidoc Technology Corporation
Chemistry · 391d