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
8713–8736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2023
Swoop® Portable MR Imaging System®
K232760 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Oct 06, 2023
Arthrex FiberTape and TigerTape Cerclage Sutures
K232755 · HTN
Arthrex, Inc.
Orthopedic · 28d
Cleared Oct 06, 2023
2.7 mm GRYPHON™ Flex Knotless PEEK Anchor
K232492 · MBI
Medos International SARL
Orthopedic · 50d
Cleared Oct 06, 2023
ProtekDuo Veno-Venous Cannula Sets
K232480 · PZS
Cardiacassist, Inc.
Cardiovascular · 51d
Cleared Oct 06, 2023
JuggerKnot Soft Anchor OC
K232411 · MBI
Riverpoint Medical, LLC
Orthopedic · 57d
Cleared Oct 06, 2023
Cautery Protective Actuation System (CPAS)
K232407 · GEI
Safer Surgeries Medical Devices, LLC
General & Plastic Surgery · 57d
Cleared Oct 06, 2023
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
K232276 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 67d
Cleared Oct 06, 2023
Ascend VBR System, Ascend NanoTec VBR System
K232173 · MQP
Alphatec Spine, Inc.
Orthopedic · 77d
Cleared Oct 06, 2023
IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
K232056 · OHT
Dongguan Lide Electric Appliance Co.,...
General & Plastic Surgery · 87d
Cleared Oct 06, 2023
Vial Adapter
K232055 · LHI
Shanghai Lingfu Technology Co., Ltd.
General Hospital · 87d
Cleared Oct 06, 2023
Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with...
K232046 · PIF
Xeridiem Medical Devices, A Spectrum...
Gastroenterology & Urology · 88d
Cleared Oct 06, 2023
Invictus Robotic Navigation Instruments
K232044 · OLO
Alphatec Spine, Inc.
Orthopedic · 88d
Cleared Oct 06, 2023
ProBeam 360° Proton Therapy System v2.0 (Multiroom)
K231863 · LHN
Varian Medical Systems, Inc.
Radiology · 105d
Cleared Oct 06, 2023
Standard Staple-Line Reinforcement (SSLR23)
K231603 · OXC
Standard Bariatrics, Inc.
General & Plastic Surgery · 127d
Cleared Oct 06, 2023
Nutricair Enteral Syringe with ENFit
K231300 · PNR
Cair Lgl
Gastroenterology & Urology · 155d
Cleared Oct 06, 2023
EARP Nerve Cuff Electrode
K230853 · ETN
Nvision Biomedical Technologies, Inc.
Neurology · 192d
Cleared Oct 06, 2023
Patient Examination Gloves
K230777 · LZA
3A Glove Sdn. Bhd.
General Hospital · 199d
Cleared Oct 06, 2023
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
K230265 · DSI
Infobionic, Inc.
Cardiovascular · 248d
Cleared Oct 06, 2023
Denti.AI Detect
K230144 · MYN
Denti.Ai Technology, Inc.
Radiology · 261d
Cleared Oct 06, 2023
THE Cover
K230091 · NPL
Purgo Biologics, Inc.
Dental · 267d
Cleared Oct 06, 2023
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
K223926 · FAJ
Medimaging Integrated Solution, Inc...
Gastroenterology & Urology · 280d
Cleared Oct 06, 2023
Vivio® LVEDP System
K223905 · QUO
Avicena, LLC
Cardiovascular · 282d
Cleared Oct 06, 2023
accufit
K223802 · IPF
Mettler Electronics Corporation
Physical Medicine · 291d
Cleared Oct 06, 2023
Disposable Sterile Syringe
K221777 · FMF
Weihai Shengjie Medical Technology...
General Hospital · 472d