FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
7273–7296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2024
Modus IR
K231986 · IZI
Synaptive Medical, Inc.
Neurology · 264d
Cleared Mar 22, 2024
Idys® C ZP 3DTi
K240715 · OVE
Clariance
Orthopedic · 7d
Cleared Mar 22, 2024
STRUXXURE® MCS Anterior Cervical Plate System
K240690 · KWQ
Nexxt Spine
Orthopedic · 9d
Cleared Mar 22, 2024
uMR Omega
K240540 · LNH
Shanghai United Imaging Healthcare...
Radiology · 25d
Cleared Mar 22, 2024
Esophageal TTS Stent
K240522 · ESW
Taewoong Medical
Gastroenterology & Urology · 28d
Cleared Mar 22, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8...
K240225 · PPN
Shockwave Medical, Inc.
Cardiovascular · 56d
Cleared Mar 22, 2024
Pilling Tracheostomy Tubes
K233713 · BTO
Teleflex Medical
Anesthesiology · 123d
Cleared Mar 22, 2024
BAHADIR STERILIZATION CONTAINERS
K233578 · KCT
Bahadir USA, LLC
General Hospital · 136d
Cleared Mar 22, 2024
SeptAlign
K233569 · NHB
Spirair, Inc.
Ear, Nose, Throat · 137d
Cleared Mar 22, 2024
The Vest APX System (PVAPX1)
K233441 · BYI
Baxter Healthcare Corportation
Anesthesiology · 156d
Cleared Mar 22, 2024
Dukal SMS Sterilization Wrap
K233262 · FRG
Dukal, LLC
General Hospital · 175d
Cleared Mar 22, 2024
Augment Off-Axis Instrument System
K233148 · PHX
Fix Surgical
Orthopedic · 177d
Cleared Mar 22, 2024
RELIEF™ Ureteral Stent Kit
K232920 · FAD
Ureteral Stent Company
Gastroenterology & Urology · 185d
Cleared Mar 22, 2024
Corsano CardioWatch 287-2 System
K232548 · MSX
Corsano Health B.V.
Cardiovascular · 212d
Cleared Mar 22, 2024
syngo.CT Brain Hemorrhage
K232431 · QAS
Siemens Medical Solutions USA, Inc.
Radiology · 224d
Cleared Mar 22, 2024
Vios Monitoring System(TM) Model 2050
K232354 · DRT
Murata Vios, Inc.
Cardiovascular · 228d
Cleared Mar 22, 2024
MAGNETOM Terra
K232322 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 232d
Cleared Mar 22, 2024
aprevo® anterior and lateral lumbar interbody fusion device, aprevo®...
K232282 · MAX
Carlsmed, Inc.
Orthopedic · 235d
Cleared Mar 22, 2024
FITBONE® Transport and Lengthening System
K232169 · HSB
Orthofix Srl
Orthopedic · 245d
Cleared Mar 22, 2024
Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600...
K232067 · ODC
Medivators (A Subsidiary of Steris...
Gastroenterology & Urology · 255d
Cleared Mar 22, 2024
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in)
K231953 · FRO
Coloplast Corp.
General & Plastic Surgery · 266d
Cleared Mar 22, 2024
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential,...
K231938 · LZA
O&M Halyard, Inc.
General Hospital · 266d
Cleared Mar 22, 2024
Digital Ultrasonic Diagnostic Imaging System (Model: F6)
K231930 · IYN
Guangdong Youkey Medical Co., Ltd.
Radiology · 266d
Cleared Mar 22, 2024
Elecsys PTH , Elecsys PTH STAT
K231927 · CEW
Roche Diagnostics
Chemistry · 266d