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
58489–58512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2007
BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER
K072008 · DRG
Braemar, Inc.
Cardiovascular · 72d
Cleared Oct 03, 2007
ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E
K072039 · NBW
Taidoc Technology Corporation
Chemistry · 70d
Cleared Oct 03, 2007
NOVATOME, MODEL: SU101-50
K072051 · DWZ
Scholten Surgical Instruments, Inc.
Cardiovascular · 69d
Cleared Oct 03, 2007
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K072148 · JOH
Cook, Inc.
Anesthesiology · 61d
Cleared Oct 03, 2007
SULTAN TOOTH ROOT DESENSITIZER
K072342 · LBH
Dentsply International, Inc.
Dental · 43d
Cleared Oct 03, 2007
COOLTOUCH, MODEL LC215,COOLLIPO
K072424 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 35d
Cleared Oct 03, 2007
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA...
K072512 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 27d
Cleared Oct 03, 2007
FORU, MODEL EQ30
K072630 · INI
Kwang Yang Motor Co., Ltd.
Physical Medicine · 15d
Cleared Oct 03, 2007
SUNIRAY 5.2
K072665 · LLZ
Orangedental GmbH & Co. KG
Radiology · 12d
Cleared Oct 02, 2007
REPROCESSED TROCARS
K070059 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 270d
Cleared Oct 02, 2007
MODIFICATION TO BIOSTAR OIA SHIGATOX
K071799 · GNA
Iverness Medical Professional...
Microbiology · 92d
Cleared Oct 02, 2007
HABIB VESEAL
K072126 · GEI
Emcision , Ltd.
General & Plastic Surgery · 61d
Cleared Oct 02, 2007
AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
K072606 · JAK
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Oct 01, 2007
SLEUTH IMPLANTABLE ECG MONITORING SYSTEM
K063035 · MXC
Transnoma Medical, Inc.
Cardiovascular · 367d
Cleared Oct 01, 2007
AMSURE NEBULIZER
K070411 · CAF
Amsino International, Inc.
Anesthesiology · 231d
Cleared Oct 01, 2007
DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES
K071397 · CAW
Sunrise Medical
Anesthesiology · 133d
Cleared Oct 01, 2007
LIAISON 25 OH VITAMIN D TOTAL
K071480 · MRG
DiaSorin, Inc.
Chemistry · 125d
Cleared Oct 01, 2007
MONACO RTP SYSTEM
K071938 · MUJ
Computerized Medical Systems, Inc.
Radiology · 80d
Cleared Oct 01, 2007
GATECT-RT
K072171 · IYE
Vision RT Limited
Radiology · 56d
Cleared Oct 01, 2007
MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
K072468 · KPS
Spectrum Dynamics , Ltd.
Radiology · 27d
Cleared Oct 01, 2007
ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
K072624 · NHA
Astra Tech AB
Dental · 14d
Cleared Sep 28, 2007
MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
K061519 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 484d
Cleared Sep 28, 2007
ARCHITECT SIROLIMUS ASSAY
K070822 · NRP
Fujirebio Diagnostics,Inc.
Toxicology · 186d
Cleared Sep 28, 2007
NEUTROPHASE WOUND CLEANSER
K071056 · FRO
Novabay Pharmaceuticals
General & Plastic Surgery · 165d