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
24145–24168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 2018
b-ONE Total Knee System
K180446 · JWH
B-One Ortho, Corp.
Orthopedic · 234d
Cleared Oct 12, 2018
Endophys Pressure Sensing Sheath Kit
K180620 · DYB
Endophys Holdings, LLC
Cardiovascular · 217d
Cleared Oct 12, 2018
AG 100s
K180991 · BSK
Hospitech Respiration , Ltd.
Anesthesiology · 179d
Cleared Oct 12, 2018
Juell 3D Volo Base
K181220 · EBI
Park Dental Research Corporation
Dental · 158d
Cleared Oct 12, 2018
OSSDSIGN Cranioplug
K181539 · GXR
Ossdsign AB
Neurology · 123d
Cleared Oct 12, 2018
BKS Revision Sleeves System
K181569 · JWH
Ortho Development Corporation
Orthopedic · 120d
Cleared Oct 12, 2018
Thorecon Rigid Fixation System
K181607 · JDQ
A & E Medical Corporation
Orthopedic · 115d
Cleared Oct 12, 2018
X-BOLT Hip Fracture Fixation System
K181640 · HSB
X-Bolt Orthopaedics
Orthopedic · 113d
Cleared Oct 12, 2018
EIT Cellular Titanium® Lumbar Cage LLIF
K181644 · MAX
Eit Emerging Implant Technologies GmbH
Orthopedic · 112d
Cleared Oct 12, 2018
Radial Medical Compression System
K181651 · JOW
Radial Medical, Inc.
Cardiovascular · 112d
Cleared Oct 12, 2018
Life Spine Laminoplasty System
K181717 · NQW
Life Spine, Inc.
Orthopedic · 106d
Cleared Oct 12, 2018
ADAPT for Gamma3, Gamma3
K181848 · OLO
Stryker GmbH
Orthopedic · 93d
Cleared Oct 12, 2018
Percuvance Percutaneous Surgical System
K181852 · GEI
Teleflexmedical, Inc.
General & Plastic Surgery · 93d
Cleared Oct 12, 2018
Integra TITAN Reverse Shoulder System
K181999 · PHX
Integra LifeSciences Corporation
Orthopedic · 78d
Cleared Oct 12, 2018
MAGNETOM Sola
K182129 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Oct 12, 2018
uMI 550 PET/CT System
K182237 · KPS
Shanghai United Imaging Healthcare...
Radiology · 56d
Cleared Oct 12, 2018
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted,...
K182247 · LPL
Vizionfocus, Inc.
Ophthalmic · 53d
Cleared Oct 12, 2018
3.0T Air MP M, 3.0T Air MP L
K182504 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 30d
Cleared Oct 12, 2018
Penumbra System (Modified 110 Aspiration Tubing)
K182522 · NRY
Penumbra, Inc.
Neurology · 29d
Cleared Oct 12, 2018
Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe...
K182536 · PHX
Exactech, Inc.
Orthopedic · 28d
Cleared Oct 11, 2018
LS OIL
K173920 · EKX
J. Morita USA, Inc.
Dental · 293d
Cleared Oct 11, 2018
OmniPore DUROMAX Surgical Implants
K180249 · JEY
Matrix Surgical Holdings, LLC/Matrix...
Dental · 255d
Cleared Oct 11, 2018
Ergoline Prestige 1600 Hybrid Performance
K180555 · LEJ
Jk Holding GmbH
General & Plastic Surgery · 224d
Cleared Oct 11, 2018
Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
K180680 · LFD
Laclede, Inc.
Dental · 210d