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
60241–60264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2007
BRACHYSCIENCES STRANDPORT
K062214 · KXK
Worldwide Medical Technologies, LLC
Radiology · 212d
Cleared Mar 01, 2007
DERMA YAG
K062762 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 167d
Cleared Mar 01, 2007
ERCHONIA IOTO_240
K062792 · EGJ
Erchonia Medical, Inc.
Physical Medicine · 164d
Cleared Mar 01, 2007
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
K062840 · GGN
Biosite Incorporated
Hematology · 160d
Cleared Mar 01, 2007
TOP FINE INSULIN SYRINGE
K063348 · FMF
Daejin Tech Medical Manufacturing...
General Hospital · 115d
Cleared Mar 01, 2007
URINE CHEMISTRY ANALYZER UR-50
K063390 · JIL
Ind Diagnostic, Inc.
Chemistry · 112d
Cleared Mar 01, 2007
DELUXE NEBULIZER
K063449 · CAF
Access Point Medical, LLC
Anesthesiology · 106d
Cleared Mar 01, 2007
VARIAN ESOPHAGUS BOUGIE APPLICATOR
K063815 · JAQ
Varian Medical Systems
Radiology · 69d
Cleared Mar 01, 2007
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
K063847 · FDS
Fujinon, Inc.
Radiology · 64d
Cleared Mar 01, 2007
AMS SINGLE INCISION SLING SYSTEM (SIS-0)
K070065 · PAH
American Medical Systems, Inc.
Gastroenterology & Urology · 52d
Cleared Mar 01, 2007
RADIESSE LARYNGEAL IMPLANT
K070090 · MIX
Bioform Medical, Inc.
Ear, Nose, Throat · 50d
Cleared Mar 01, 2007
CREATION CP-ZI PORCELAIN
K070114 · EIH
Jensen Industries, Inc.
Dental · 48d
Cleared Mar 01, 2007
MAXHEALTH MECHANICAL WHEELCHAIR, K1
K070176 · IOR
Maxhealth Corp.
Physical Medicine · 42d
Cleared Mar 01, 2007
VELOCITYAIS
K070248 · LLZ
Velocity Medical Solutions, LLC
Radiology · 35d
Cleared Mar 01, 2007
SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES
K070294 · HSB
Synthes (Usa)
Orthopedic · 29d
Cleared Feb 28, 2007
ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI
K062197 · NHA
Atlantis Components, Inc.
Dental · 211d
Cleared Feb 28, 2007
ZOLL M SERIES WITH REAL CPR HELP
K062537 · MKJ
ZOLL Medical Corporation
Cardiovascular · 183d
Cleared Feb 28, 2007
CRITIVIEW, MODEL CRV3
K062977 · DPW
Critisense , Ltd.
Cardiovascular · 152d
Cleared Feb 28, 2007
CTLOGICS NAVIGATIONS SYSTEMS
K063408 · HAW
Praxim Medivision, SA
Neurology · 107d
Cleared Feb 28, 2007
CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
K063465 · EGJ
Iomed, Inc.
Physical Medicine · 104d
Cleared Feb 28, 2007
SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL...
K063471 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 104d
Cleared Feb 28, 2007
D-STAT HANDLE, MODEL 8500-053
K063871 · DXC
Vascular Solutions, Inc.
Cardiovascular · 61d
Cleared Feb 28, 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES
K070145 · LYZ
Wuxi Shenzhou Plastic Products Co., Ltd.
General Hospital · 43d
Cleared Feb 28, 2007
AMPLATZER RELIANT CATHETER DELIVERY SYSTEM
K070238 · DQY
Aga Medical Corp.
Cardiovascular · 34d