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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
41641–41664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2013
MUSCLE STIMULATION SYSTEM
K123642 · IPF
Niveus Medical, Inc.
Physical Medicine · 123d
Cleared Mar 29, 2013
SWIFT FX NANO
K123789 · BZD
Resmed, Ltd.
Anesthesiology · 109d
Cleared Mar 29, 2013
IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE
K124008 · NHA
Ivoclar Vivadent, Agin
Dental · 92d
Cleared Mar 29, 2013
RMGI FILL
K130223 · EMA
Pulpdent Corporation
Dental · 59d
Cleared Mar 29, 2013
D4000 DRIVE SYSTEM
K130497 · HBC
Linvatec Corporation D/B/A Conmed...
Neurology · 31d
Cleared Mar 29, 2013
BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER
K130537 · NEU
Biopsy Sciences, LLC
General & Plastic Surgery · 28d
Cleared Mar 29, 2013
ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
K130653 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 17d
Cleared Mar 28, 2013
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
K121743 · BXN
Sunmed, LLC
Anesthesiology · 288d
Cleared Mar 28, 2013
MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
K122175 · NDN
Tecres S.P.A.
Orthopedic · 248d
Cleared Mar 28, 2013
CARDIOMEM
K122272 · MWJ
Getemed Medizin- Und...
Cardiovascular · 241d
Cleared Mar 28, 2013
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
K122744 · NUH
Prospera Corporation
Neurology · 202d
Cleared Mar 28, 2013
BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
K122770 · HRS
Biomet Manufacturing Corp
Orthopedic · 199d
Cleared Mar 28, 2013
TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
K122850 · ODP
Meditech Advisors, LLC
Orthopedic · 191d
Cleared Mar 28, 2013
INTESS LUMBAR CAGE
K123100 · MAX
Kalitec Direct, LLC
Orthopedic · 177d
Cleared Mar 28, 2013
ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
K123139 · ELC
Asi Medical, Inc.
Dental · 174d
Cleared Mar 28, 2013
STRYKER VENOM ELECTRODES AND CANNULAE
K123178 · GXI
Stryker Instruments, Instruments Div.
Neurology · 170d
Cleared Mar 28, 2013
1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
K123272 · MOS
Neocoil, LLC
Radiology · 160d
Cleared Mar 28, 2013
BARRICADE EMBOLIZATION COIL SYSTEM
K123338 · HCG
Blockade Medical
Neurology · 148d
Cleared Mar 28, 2013
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM
K123512 · DZE
Biodenta Swiss AG
Dental · 135d
Cleared Mar 28, 2013
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
K123624 · EWO
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 125d
Cleared Mar 28, 2013
AXSOS 3 TI LOCKING PLATE SYSTEM
K123964 · HRS
Stryker Trauma AG
Orthopedic · 92d
Cleared Mar 28, 2013
QUANTIEN MEASUREMENT SYSTEM
K123984 · DQK
Radi Medical Systems AB
Cardiovascular · 92d
Cleared Mar 28, 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130176 · NKB
Orthofix
Orthopedic · 62d
Cleared Mar 28, 2013
5MP MONOCHROME LCD MONITOR, RADIFORCE GX540
K130336 · LLZ
Eizo Nanao Corporation
Radiology · 45d