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
59233–59256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2007
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE...
K071253 · DTM
Medtronic Vascular
Cardiovascular · 60d
Cleared Jul 03, 2007
ARTHREX FIBERWIRE
K071622 · GAT
Arthrex, Inc.
General & Plastic Surgery · 19d
Cleared Jul 03, 2007
LIQUICHEK TUMOR MARKER CONTROL
K071675 · JJY
Bio-Rad Laboratories
Immunology · 14d
Cleared Jul 02, 2007
CRANIAL SOLUTION ORTHOSIS
K063133 · MVA
Cranial Solutions
Neurology · 262d
Cleared Jul 02, 2007
SIGMA M
K063837 · MUH
Instrumentarium Dental, Palodex Group OY
Radiology · 188d
Cleared Jul 02, 2007
POWERLASER
K070516 · ILY
Powermedic Aps
Physical Medicine · 130d
Cleared Jul 02, 2007
Z6 STIMULATOR
K070743 · JOQ
St Cardio Technologies, LLC
Cardiovascular · 108d
Cleared Jul 02, 2007
MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM
K070846 · FTL
Prosurg, Inc.
General & Plastic Surgery · 96d
Cleared Jul 02, 2007
MYLAB40
K070903 · ITX
Esaote Europe B.V.
Radiology · 91d
Cleared Jul 02, 2007
DEPUY CAS HEMI ASR HIP INSTRUMENTS
K071334 · HAW
DePuy Orthopaedics, Inc.
Neurology · 52d
Cleared Jul 02, 2007
ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
K071569 · MBI
Biomet, Inc.
Orthopedic · 24d
Cleared Jul 02, 2007
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
K071645 · MWI
Omron Healthcare, Inc.
Cardiovascular · 17d
Cleared Jun 29, 2007
PALM ECG RECORDER, MODEL EP-201/202
K061123 · DPS
Parama-Tech Company., Ltd.
Cardiovascular · 431d
Cleared Jun 29, 2007
MEDICK MHM200 PERSONAL HEART MONITOR
K063339 · MLO
Medick Healthcare , Ltd.
Cardiovascular · 235d
Cleared Jun 29, 2007
A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
K063526 · CAH
A-M Systems, Inc.
General Hospital · 219d
Cleared Jun 29, 2007
TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE
K063681 · FLE
Mediline Italia S.R.L.
General Hospital · 200d
Cleared Jun 29, 2007
SPACE 360 DELIVERY SYSTEM
K070351 · NDN
Dfine, Inc.
Orthopedic · 143d
Cleared Jun 29, 2007
SILHOUETTE, MODEL 1000.01
K070426 · FXN
Aranz Medical Limited
General & Plastic Surgery · 136d
Cleared Jun 29, 2007
POLYMAP PWR-08-03
K070559 · NBW
Polymap Wireless
Chemistry · 122d
Cleared Jun 29, 2007
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
K070613 · LJS
AngioDynamics, Inc.
General Hospital · 116d
Cleared Jun 29, 2007
THE INHIBITOR, MODEL 001
K070648 · KLW
Melmedtronics, Inc.
Ear, Nose, Throat · 113d
Cleared Jun 29, 2007
INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
K070696 · GWJ
Interacoustics A/S
Neurology · 108d
Cleared Jun 29, 2007
AVANTE Z
K070699 · EIH
Pentron Ceramics, Inc.
Dental · 108d
Cleared Jun 29, 2007
NARROW NECK TEMPORARY COPING
K070744 · NHA
Institut Straumann AG
Dental · 105d