FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
24745–24768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 11, 2018
SCARLET SRF
K180872 · GEI
VIOL Co., Ltd.
General & Plastic Surgery · 191d
Cleared Oct 11, 2018
NuFACE Trinity
K181008 · NFO
Carol Cole Company Dba Nuface
Neurology · 177d
Cleared Oct 11, 2018
AxSOS 3 Ti
K181091 · HRS
Stryker GmbH
Orthopedic · 170d
Cleared Oct 11, 2018
NeoMatriX Wound Matrix
K181330 · KGN
Nextgen Biologics, Inc.
General & Plastic Surgery · 146d
Cleared Oct 11, 2018
Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe...
K181426 · PNR
Jiangsu Micsafe Medical Technology...
Gastroenterology & Urology · 133d
Cleared Oct 11, 2018
OnePacs System
K181460 · LLZ
Onepacs, LLC
Radiology · 129d
Cleared Oct 11, 2018
Fingertip Pulse Oximeter
K181503 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 126d
Cleared Oct 11, 2018
Sirona Dental CAD/CAM System
K181520 · NHA
Dentsply Sirona
Dental · 122d
Cleared Oct 11, 2018
DemeTECH PTFE Nonabsorbable Surgical Suture
K181578 · NBY
Demetech Corporation
General & Plastic Surgery · 118d
Cleared Oct 11, 2018
E-CUBE 8
K181617 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 114d