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
42889–42912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2012
TAP PAP NASAL PILLOW MASK
K122350 · BZD
Airway Management, Inc.
Anesthesiology · 90d
Cleared Nov 01, 2012
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K122496 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 77d
Cleared Nov 01, 2012
LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
K122637 · FST
Stryker Spine
General & Plastic Surgery · 64d
Cleared Oct 31, 2012
ERGOSELECT/GE
K112121 · ISD
Ergoline GmbH
Physical Medicine · 464d
Cleared Oct 31, 2012
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
K113602 · HRS
Aap Implantate AG
Orthopedic · 331d
Cleared Oct 31, 2012
CANOPY LAMINOPLASTY FIXATION SYSTEM
K121732 · NQW
Globus Medical, Inc.
Orthopedic · 140d
Cleared Oct 31, 2012
COSENSE
K121768 · CCJ
Capnia, Inc.
Anesthesiology · 138d
Cleared Oct 31, 2012
REX ANTERIOR CERVICAL PLATE SYSTEM
K121862 · KWQ
Dio Medical Co., Ltd.
Orthopedic · 127d
Cleared Oct 31, 2012
LOFRIC PRIMO, LOFRIC HYDRO-KIT
K122078 · EZD
Astra Tech, Inc.
Gastroenterology & Urology · 107d
Cleared Oct 31, 2012
WINX SLEEP THERAPY SYSTEM
K122130 · OZR
Apnicure, Inc.
Anesthesiology · 105d
Cleared Oct 31, 2012
CERTEX SPINAL IMPLANT SYSTEM
K122163 · MNI
X-Spine Systems, Inc.
Orthopedic · 103d
Cleared Oct 31, 2012
STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM
K122313 · JEY
Stryker
Dental · 91d
Cleared Oct 31, 2012
QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
K122314 · MBI
Cayenne Medical, Inc.
Orthopedic · 91d
Cleared Oct 31, 2012
DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS
K122395 · HSN
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Oct 31, 2012
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
K122434 · NHB
Medtronic Xomed
Ear, Nose, Throat · 82d
Cleared Oct 31, 2012
MODIFIED TREVO RETRIEVER
K122478 · NRY
Concentric Medical, Inc.
Neurology · 78d
Cleared Oct 31, 2012
MULTIFLEX TINNITUS TECHNOLOGY
K122876 · KLW
Starkey Laboratories
Ear, Nose, Throat · 42d
Cleared Oct 30, 2012
BIOPRO HEMI-EDGE TOE SYSTEM
K121973 · KWD
Biopro, Inc.
Orthopedic · 117d
Cleared Oct 26, 2012
LEGACY-500
K111588 · JFB
Mt Tables, LLC
Physical Medicine · 507d
Cleared Oct 26, 2012
THE CANARY SYSTEM
K112139 · NBL
Quantum Dental Technologies, Inc.
Dental · 458d
Cleared Oct 26, 2012
SPERMFREEZE SOLUTION
K113786 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 309d
Cleared Oct 26, 2012
SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL...
K120127 · KOB
Swan Valley Medical, Incorporated
Gastroenterology & Urology · 283d
Cleared Oct 26, 2012
ZOLL FULLY AUTOMATIC AED PLUS
K120406 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 260d
Cleared Oct 26, 2012
SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
K120796 · JAK
Superdimension, Inc.
Radiology · 225d