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

Filters: Cleared only ×
175,820 results
39385–39408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 24, 2013
INTUITION - TDA, TVA, PARAMETRIC MAPPING
K131447 · LLZ
Terarecon,Inc.
Radiology · 218d
Cleared Dec 24, 2013
VELOX ANTERIOR CERVICAL PLATE SYSTEM
K131521 · KWQ
Spinecraft, LLC
Orthopedic · 210d
Cleared Dec 24, 2013
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
K131724 · MQP
Pioneer Surgical Technology, Inc.
Orthopedic · 195d
Cleared Dec 24, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K132511 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 134d
Cleared Dec 24, 2013
COROENT STERILE IMPLANTS SYSTEM
K132601 · MAX
Nu Vasive, Incorporated
Orthopedic · 126d
Cleared Dec 24, 2013
LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE
K132787 · HRS
Aap Implantate AG
Orthopedic · 109d
Cleared Dec 24, 2013
VENUE 50
K133431 · IYN
Ge Healthcare
Radiology · 46d
Cleared Dec 23, 2013
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
K122932 · JOH
Fogless International AB
Anesthesiology · 455d
Cleared Dec 23, 2013
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
K131787 · HRN
Keeler, Ltd.
Ophthalmic · 188d
Cleared Dec 23, 2013
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
K131821 · MID
Phadia US, Inc.
Immunology · 186d
Cleared Dec 23, 2013
IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
K131901 · BZD
3B Medical, Inc.
Anesthesiology · 181d
Cleared Dec 23, 2013
ASCOT
K132310 · KWQ
Backroads Consulting, Inc.
Orthopedic · 151d
Cleared Dec 23, 2013
TOTALSHIELD SURGICAL HELMET SYSTEM
K132386 · FYA
Zimmer, Inc.
General Hospital · 144d
Cleared Dec 23, 2013
CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER...
K132500 · EZD
Cure Medical, LLC
Gastroenterology & Urology · 136d
Cleared Dec 23, 2013
EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR...
K132854 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 102d
Cleared Dec 23, 2013
LIPIFLOW THERMAL PULSATION SYSTEM
K133127 · ORZ
Tearscience, Inc.
Ophthalmic · 84d
Cleared Dec 23, 2013
LAURIMED POLYPVAC MICRODEBRIDER
K133133 · ERL
Laurimed, LLC
Ear, Nose, Throat · 84d
Cleared Dec 23, 2013
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
K133627 · LPL
CooperVision, Inc.
Ophthalmic · 27d
Cleared Dec 23, 2013
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
K133634 · LJS
Cook, Inc.
General Hospital · 27d
Cleared Dec 20, 2013
AGGREGUIDE
K122162 · JOZ
Aggredyne, Inc.
Hematology · 518d
Cleared CT Dec 20, 2013
AIR BARRIER SYSTEM (ABS)
K123006 · ORC
Nimbic Systems, Inc.
General Hospital · 449d
Cleared Dec 20, 2013
TONE-A-MATIC
K130052 · IPF
Tone-A-Matic International, Inc.
Physical Medicine · 345d
Cleared Dec 20, 2013
GENPRIME DRUGS OF ABUSE READER SYSTEM
K130082 · DKZ
Genprime, Inc.
Chemistry · 340d
Cleared Dec 20, 2013
BERNOULLI ENTERPRISE SOFTWARE
K130208 · MHX
Cardiopulmonary Corp.
Cardiovascular · 326d