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
60313–60336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2007
NANOTITE DENTAL IMPLANTS
K062432 · DZE
Implant Innovations, Inc.
Dental · 185d
Cleared Feb 22, 2007
HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT
K062444 · EZD
Oasis Medikal Urunler Kimya Sanayi VE...
Gastroenterology & Urology · 185d
Cleared Feb 22, 2007
MAXO2 CU
K063488 · CCL
Maxtec, Inc.
Anesthesiology · 97d
Cleared Feb 22, 2007
SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM
K063531 · LFL
Sra Developments, Ltd.
General & Plastic Surgery · 92d
Cleared Feb 22, 2007
BIPAP AUTOSV
K063540 · MNS
Respironics, Inc.
Anesthesiology · 90d
Cleared Feb 22, 2007
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL
K063596 · LYC
Novabone Products, LLC
Dental · 80d
Cleared Feb 22, 2007
AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1
K063639 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 77d
Cleared Feb 22, 2007
AMS SMART SLING SYSTEM
K063713 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 70d
Cleared Feb 22, 2007
POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED)
K070076 · LYZ
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 45d
Cleared Feb 22, 2007
560 HIGH DEFINITION CAMERA SYSTEM
K070266 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 24d
Cleared Feb 21, 2007
C300 SERIES AIR NEBULIZER COMPRESSOR
K062952 · CAF
Choice Smart Health Care Co. , Ltd.
Anesthesiology · 145d
Cleared Feb 21, 2007
ACCU-CHEK ULTRAFLEX INFUSION SET
K070189 · FPA
Disetronic Medical Systems AG
General Hospital · 30d
Cleared Feb 21, 2007
SBI LATERAL RADIO CAPITELLUM
K070236 · JDB
Small Bone Innovations, Inc.
Orthopedic · 27d
Cleared Feb 20, 2007
BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
K062527 · LYY
Multisafe Sdn. Bhd.
General Hospital · 176d
Cleared Feb 20, 2007
STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
K062565 · MKU
Princeton BioMeditech Corp.
Chemistry · 173d
Cleared Feb 20, 2007
PATHIAM IMAGING SOFTWARE FOR HER2/NEU
K062756 · NOT
Bioimagene, Inc.
Pathology · 159d
Cleared Feb 20, 2007
BIPAP SYNCHRONY
K063533 · MNS
Respironics, Inc.
Anesthesiology · 90d
Cleared Feb 20, 2007
ALTRA FX HIP SYSTEM
K063614 · KWA
Biomet Manufacturing Corp
Orthopedic · 77d
Cleared Feb 20, 2007
BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
K063704 · EEG
Beks Incorporated
Dental · 69d
Cleared Feb 20, 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
K070037 · LYZ
Shijiazhuang Lianhe Shunda Plastic...
General Hospital · 48d
Cleared Feb 20, 2007
SOPRO 162 CAMERA
K070102 · GCJ
Sopro
General & Plastic Surgery · 41d
Cleared Feb 16, 2007
INFINITY TELESMART TELEMETRY SYSTEM
K061379 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 275d
Cleared Feb 16, 2007
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND...
K062437 · IKT
Technomed Europe
Neurology · 189d
Cleared Feb 16, 2007
MONITORING EAR THERMOMETER, MODEL BTM-D1A
K062445 · FLL
Rio Flexon Technology Co., Ltd.
General Hospital · 178d