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
8665–8688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2023
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K233408 · QHE
Materialise NV
Orthopedic · 34d
Cleared Nov 09, 2023
SYMPHONY OCT System
K233366 · NKG
Medos International SARL
Orthopedic · 38d
Cleared Nov 09, 2023
Dental Handpiece, Wireless Endodontic Handpiece, endoit
K232810 · EKX
Micro-Nx Co., Ltd.
Dental · 58d
Cleared Nov 09, 2023
Disposable Endoscope Injection Needles
K232442 · FBK
Zhejiang Soudon Medical Technology...
Gastroenterology & Urology · 87d
Cleared Nov 09, 2023
Longeviti ClearFit OTS Cranial Implant
K231920 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 133d
Cleared Nov 09, 2023
Glenoid Reconstruction System – Full Wedge Baseplate
K231911 · PHX
Medacta International S.A.
Orthopedic · 133d
Cleared Nov 09, 2023
PRIME-XV FreezIS DMSO-Free MD
K231804 · NDS
Fujifilm Irvine Scientific
Gastroenterology & Urology · 142d
Cleared Nov 09, 2023
ARK Hydrocodone Assay
K231752 · DJG
ARK Diagnostics, Inc.
Chemistry · 147d
Cleared Nov 09, 2023
Flush Syringe (Prefilled 0.9% normal saline solution)
K231724 · NGT
Spm Medicare Pvt. , Ltd.
General Hospital · 149d
Cleared Nov 09, 2023
MAGNETOM Free.Max
K231617 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 160d
Cleared Nov 09, 2023
Power Wheelchair, W5521
K231508 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 168d
Cleared Nov 09, 2023
Neuronaute Plus
K231366 · GWQ
Bioserenity Sas
Neurology · 182d
Cleared Nov 09, 2023
TissueStat
K231277 · NBY
Durastat, LLC
General & Plastic Surgery · 190d
Cleared Nov 09, 2023
Cardio P1
K231150 · DPS
Bionet Co., Ltd.
Cardiovascular · 202d
Cleared Nov 09, 2023
Oxygen Concentrator
K230969 · CAW
Jiangsu Jumao X-Care Medical...
Anesthesiology · 218d
Cleared Nov 09, 2023
Flowflex COVID-19 Antigen Home Test
K230828 · QYT
ACON Laboratories, Inc.
Microbiology · 227d
Cleared Nov 09, 2023
BraveCX
K223754 · QFM
Bering, Ltd.
Radiology · 329d
Cleared Nov 09, 2023
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K223682 · PBY
Sirius Medical Systems B.V.
General & Plastic Surgery · 336d
Cleared Nov 09, 2023
LILY Extension Tube and Needleless Connector
K222780 · FPA
Lily Medical Corporation
General Hospital · 421d
Cleared Nov 08, 2023
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
K232886 · MBI
Healthium Medtech Limited
Orthopedic · 51d
Cleared Nov 08, 2023
NerivioInfinity
K232152 · QGT
Theranica Bioelectronics , Ltd.
Neurology · 112d
Cleared Nov 08, 2023
da Vinci SP Surgical System
K231798 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 141d
Cleared Nov 08, 2023
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U,...
K231773 · DTZ
Qura S.R.L
Cardiovascular · 145d
Cleared Nov 08, 2023
Contour ProtégéAI
K231765 · QKB
Mim Software, Inc.
Radiology · 145d