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
5401–5424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2024
Persona the Personalized Knee System
K243247 · MBH
Zimmer, Inc.
Orthopedic · 18d
Cleared Oct 29, 2024
OC JuggerKnotless Soft Anchor
K243203 · MBI
Riverpoint Medical
Orthopedic · 28d
Cleared Oct 29, 2024
AtriCure cryoICE BOX (ACM)
K243157 · GXH
AtriCure, Inc.
Neurology · 29d
Cleared Oct 29, 2024
TRACHEOBRONXANE™ DUMON®
K243126 · NWA
Novatech SA
Anesthesiology · 29d
Cleared Oct 29, 2024
Mammotome AutoCore™ Single Insertion Core Biopsy System
K243095 · KNW
Devicor Medical Products, Inc.
General & Plastic Surgery · 29d
Cleared Oct 29, 2024
Riptide Aspiration System
K243080 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Oct 29, 2024
QIAstat-Dx Meningitis/Encephalitis (ME) Panel
K242256 · PLO
QIAGEN GmbH
Microbiology · 90d
Cleared Oct 29, 2024
Catheter Surface Flap Applicator Set (GM11011830)
K241965 · JAQ
Varian Medical Systems
Radiology · 118d
Cleared Oct 29, 2024
Video Bronchoscope System
K241612 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 146d
Cleared Oct 29, 2024
QualityFlow O2 Series (QualityFLOW O2)
K241366 · CBP
Dehas Medical Systems GmbH
Anesthesiology · 168d
Cleared Oct 29, 2024
Electric Wheelchair (ME23-EW16-BC200-01)
K241189 · ITI
Jiaxing Xiaoxiang Medical Equipment...
Physical Medicine · 183d
Cleared Oct 29, 2024
DeGen Medical Patient Specific Implant (PSI) System
K241077 · OVD
Degen Medical
Orthopedic · 193d
Cleared Oct 29, 2024
Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
K240175 · HWC
Tigon Medical
Orthopedic · 280d
Cleared Oct 28, 2024
Curiteva Porous PEEK Laminoplasty System
K243137 · NQW
Curiteva, Inc.
Orthopedic · 28d
Cleared Oct 28, 2024
Sterile Lancets for Single Use
K242622 · QRK
Ningbo Caremed Medical Products Co.,...
General & Plastic Surgery · 55d
Cleared Oct 28, 2024
Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
K242350 · NKB
Spinal Alignment Solutions, Inc.
Orthopedic · 81d
Cleared Oct 28, 2024
Catalyft™ LS Expandable Interbody System
K241992 · OVD
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 112d
Cleared Oct 28, 2024
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
K241718 · OHS
Shenzhen Aozemei Technology Co., Ltd.
General & Plastic Surgery · 136d
Cleared Oct 28, 2024
ECHELON 4000 60mm Compact Stapler (EC3D60C)
K241630 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 144d
Cleared Oct 28, 2024
MetaLite DX Digital Pathology Software
K240303 · QKQ
Jellox Biotech, Inc.
Pathology · 269d
Cleared Oct 25, 2024
TumorSight Viz
K243189 · QIH
SimBioSys, Inc.
Radiology · 25d
Cleared Oct 25, 2024
Cadence Ankle PSI System
K243174 · OYK
3D Systems, Inc.
Orthopedic · 25d
Cleared Oct 25, 2024
Salto Talaris Ankle PSI System
K243173 · OYK
3D Systems, Inc.
Orthopedic · 25d
Cleared Oct 25, 2024
Xpert® SA Nasal Complete
K243070 · NQX
Cepheid
Microbiology · 28d