FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37465–37488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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 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
Cleared May 30, 2014
OPTOSSOL COMPRESSION DEVICE SYSTEM
K140875 · JDW
Genossis, LLC
Orthopedic · 56d
Cleared May 30, 2014
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
K141124 · DSY
Vascular Flow Technologies, Ltd.
Cardiovascular · 29d
Cleared May 30, 2014
SURFLASH SAFETY I.V. CATHETER
K141138 · FOZ
Kofu Factory of Terumo Corp.
General Hospital · 28d
Cleared May 29, 2014
SENTIO MMG
K131304 · PDQ
Innovative Surgical Solutions, LLC...
Neurology · 387d
Cleared May 29, 2014
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
K131600 · JIL
Teco Diagnostics
Chemistry · 360d
Cleared May 29, 2014
MEDI PEN NEEDLE
K131954 · FMI
Shanghai Carelife International...
General Hospital · 336d
Cleared May 29, 2014
SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
K132506 · LRK
Michael D Williams Dds PA
Dental · 290d
Cleared May 29, 2014
PEEK CAGE FOR THE VERTEBRAL SPINE
K132852 · MAX
Neoortho Produtos Ortopedicos S/A
Orthopedic · 260d
Cleared May 29, 2014
MOVES SLC
K140049 · BTL
Thornhill Research, Inc.
Anesthesiology · 140d
Cleared May 29, 2014
S.E.A.L. FRACTURE FUSION TUBE
K140158 · KTT
Dne, LLC
Orthopedic · 127d
Cleared May 29, 2014
KOALA TOCO
K140163 · HFM
Clinical Innovations, LLC
Obstetrics & Gynecology · 127d
Cleared May 29, 2014
NIGHT SHIFT
K140190 · MYB
Advanced Brain Monitoring, Inc.
Ear, Nose, Throat · 125d
Cleared May 29, 2014
XGEO GF50
K140326 · KPR
Samsung Electronics Co., Ltd.
Radiology · 108d
Cleared May 29, 2014
JOURNEY II BCS CONSTRAINED INSERTS
K140555 · JWH
Smith & Nephew, Inc.
Orthopedic · 86d