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
68017–68040 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2004
CAVERMAP SURGICAL AID
K041732 · FGM
Blue Torch Medical Technologies
Gastroenterology & Urology · 88d
Cleared Sep 21, 2004
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
K041779 · FMG
Nipro Medical Corp.
General Hospital · 82d
Cleared Sep 21, 2004
MICROSCOPE SYSTEM
K041805 · EIA
Miras Mirror Imaging Solutions, Ltd.
Dental · 77d
Cleared Sep 21, 2004
ULTRASOUND CAPTURE SYSTEM
K042042 · LLZ
Heartlab, Inc.
Radiology · 54d
Cleared Sep 21, 2004
RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
K042215 · EMA
Premier Dental Products Co.
Dental · 36d
Cleared Sep 21, 2004
MODIFICATION TO: CRESCO TI IMPLANT CONCEPT
K042354 · DZE
Cresco TI Systems AB
Dental · 22d
Cleared Sep 21, 2004
AMERICAN DENTAL IMPLANT
K042462 · DZE
American Dental Implant Corporation
Dental · 11d
Cleared Sep 20, 2004
KUNG SHIN, HMEF SK203
K032878 · CAH
Kung Shin Plastics Co., Ltd.
General Hospital · 371d
Cleared Sep 20, 2004
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
K040209 · HQF
Iridex Corp
Ophthalmic · 234d
Cleared Sep 20, 2004
SILVERSITE OR CALGITROL
K041268 · MGQ
Adri
General & Plastic Surgery · 131d
Cleared Sep 20, 2004
ZEWA MFM-007 BLOOD PRESSURE MONITOR
K041491 · DXN
Zewa, Inc.
Cardiovascular · 108d
Cleared Sep 20, 2004
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
K041524 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 104d
Cleared Sep 20, 2004
FEATHERLIFT EXTENDED LENGTH APTOS THREAD
K041593 · GAW
Surgical Specialties Corp
General & Plastic Surgery · 98d
Cleared Sep 20, 2004
VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
K041863 · DHR
Ortho-Clinical Diagnostics, Inc.
Immunology · 73d
Cleared Sep 20, 2004
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
K042100 · MNI
Blackstone Medical, Inc.
Orthopedic · 47d
Cleared Sep 20, 2004
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
K042142 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 42d
Cleared Sep 20, 2004
BONE FUSION PLATE SYSTEM
K042205 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Sep 20, 2004
MACROPORE PURICEL LIPOPLASTY SYSTEM
K042261 · QPB
Macropore Biosurgery, Inc.
General & Plastic Surgery · 28d
Cleared Sep 20, 2004
BIOMARC PRELOADED TISSUE MARKER DEVICE
K042296 · NEU
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 27d
Cleared Sep 20, 2004
ULTRACLIP II US
K042341 · NEU
Inrad
General & Plastic Surgery · 21d
Cleared Sep 20, 2004
LNCS OXIMETRY SENSORS
K042346 · DQA
Masimo Corporation
Anesthesiology · 21d
Cleared Sep 20, 2004
NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
K042378 · LZA
Shijiazhuang Tillotson Rubber...
General Hospital · 19d
Cleared Sep 17, 2004
NARCOTREND, MODEL COMPACT 4.0
K033543 · OLW
Mt Monitortechnik GmbH & Co. KG
Neurology · 312d
Cleared Sep 17, 2004
EZ HUBER SAFETY INFUSION SET
K040533 · FPA
Pfm Medical, Inc.
General Hospital · 200d