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
38041–38064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 2014
BRIGHTMATTER PLANNING SOFTWARE
K140337 · LLZ
Synaptive Medical, Inc.
Radiology · 112d
Cleared Jun 02, 2014
COMPRESSYN STAPLE
K140358 · JDR
Dallen Medical, Inc.
Orthopedic · 110d
Cleared Jun 02, 2014
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND...
K140364 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 110d
Cleared Jun 02, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)
K140468 · LON
Becton, Dickinson and Company
Microbiology · 97d
Cleared Jun 02, 2014
TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
K140774 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 66d
Cleared May 30, 2014
DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
K123940 · GAM
Demetech Corp.
General & Plastic Surgery · 526d
Cleared May 30, 2014
LMA FAMILY OF AIRWAYS
K130304 · CAE
The Laryngeal Mask Co., Ltd.
Anesthesiology · 477d
Cleared May 30, 2014
T1/T2/T3 TURBINE FAMILY
K131319 · EFB
Sirona Dental Systems GmbH
Dental · 388d
Cleared May 30, 2014
A-TONE IPL SYSTEM
K131712 · ONF
Ybk Investment, Inc.
General & Plastic Surgery · 353d
Cleared CT May 30, 2014
FAMILY HEALTHWARE
K132173 · DRG
Sanitas, Inc.
Cardiovascular · 319d
Cleared May 30, 2014
X-MIND UNITY
K132378 · EHD
De Gotzen S.R.L.
Radiology · 303d
Cleared May 30, 2014
BIO-PROBE DISPOSABLE INSERT WITH
K132730 · DPT
Medtronic, Inc.
Cardiovascular · 269d
Cleared May 30, 2014
NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F
K133123 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 242d
Cleared May 30, 2014
ULTRAPRO COMFORT PLUG
K133198 · FTL
Ethicon, Inc.
General & Plastic Surgery · 225d
Cleared May 30, 2014
AERO-AL LUMBAR CAGE SYSTEM
K133328 · OVD
Stryker Corporation
Orthopedic · 213d
Cleared May 30, 2014
CP RELIEF WAND
K133779 · GZJ
Mid-America Medical Innovations, LLC
Neurology · 169d
Cleared CT May 30, 2014
WATCH-PAT200U (WP200U)
K133859 · MNR
Itamar Medical , Ltd.
Anesthesiology · 162d
Cleared May 30, 2014
ULTRASONIC MESH NEBULIZER
K140211 · CAF
Foshan Gaunying Electronics Co., Ltd.
Anesthesiology · 122d
Cleared May 30, 2014
ULTRASOUND SCANNER SYSTEM BK2300
K140428 · IYO
B-K Medical Aps
Radiology · 100d
Cleared May 30, 2014
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
K140559 · CBF
Sechrist Industries, Inc.
Anesthesiology · 86d
Cleared May 30, 2014
BODY FAT ANALYZER AND SCALE
K140594 · MNW
Conmo Electronic Company Limited
Gastroenterology & Urology · 84d
Cleared May 30, 2014
PROFEMUR TL CLASSIC LONG NECK HIP STEMS
K140676 · LZO
Microport Orthopedics, Inc.
Orthopedic · 73d
Cleared May 30, 2014
TERASON USMART3300 ULTRASOUND SYSTEM
K140773 · IYN
Teratech Corp.
Radiology · 63d
Cleared May 30, 2014
PLS (POSTERIOR LUMBAR SYSTEM)
K140787 · MNH
Sintea Plustek, LLC
Orthopedic · 60d