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
10969–10992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2023
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
K223401 · FYA
Xiamen Probtain Medical Techology...
General Hospital · 118d
Cleared Mar 07, 2023
Aquilion Precision (TSX-304A/4) V10.14 with AiCE
K223726 · JAK
Canon Medical Systems Corporation
Radiology · 84d
Cleared Mar 07, 2023
Athena III Cervical Plate System
K230301 · KWQ
Medyssey USA, Inc.
Orthopedic · 32d
Cleared Mar 07, 2023
Protrieve Sheath
K230331 · QEW
Inari Medical, Inc.
Cardiovascular · 28d
Cleared Mar 06, 2023
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
K212161 · MWI
Masimo Corporation
Anesthesiology · 602d
Cleared Mar 06, 2023
Single-Use Video Flexible Ureterorenoscope System
K221158 · FGB
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 319d
Cleared Mar 06, 2023
Pro-X1™ Trochanteric Nailing System
K221621 · HSB
X-Bolt Orthopedics
Orthopedic · 276d
Cleared Mar 06, 2023
LC ChromeFlow
K222445 · EBF
S&C Polymer Silicon- Und Composite...
Dental · 203d
Cleared Mar 06, 2023
Provata Implant System
K222457 · DZE
Southern Implants (Pty), Ltd.
Dental · 203d
Cleared Mar 06, 2023
Disposable Insulin Syringe
K222672 · FMF
Hantech Medical Device Co., Ltd.
General Hospital · 181d
Cleared Mar 06, 2023
Procedure mask/Surgical mask/Face mask
K223232 · FXX
Winner Medical Co., Ltd.
General Hospital · 138d
Cleared Mar 06, 2023
BD Vaginal Panel
K223653 · PQA
Becton, Dickinson and Company
Microbiology · 90d
Cleared Mar 06, 2023
A1417MCW/A1717MCW/F1417MCW
K223930 · MQB
H&abyz Co., Ltd.
Radiology · 66d
Cleared Mar 06, 2023
Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase...
K230315 · QHE
Materialise NV
Orthopedic · 28d
Cleared Mar 06, 2023
Savvy Surgical Mask - Level 3
K230383 · FXX
Alg Health, LLC
General Hospital · 21d
Cleared Mar 05, 2023
Nitronox Scavenger Plus
K223452 · CBN
Parker Hannifin Corporation
Anesthesiology · 110d
Cleared Mar 03, 2023
Aspira Pleural Drainage System
K212696 · DWM
Merit Medical Systems, Inc.
Anesthesiology · 555d
Cleared Mar 03, 2023
Dyna Locking Trochanteric Nail™
K221084 · HSB
Innosys
Orthopedic · 324d
Cleared Mar 03, 2023
DHX-70H, XTG-70H
K221587 · EHD
Digimed Co., Ltd.
Radiology · 275d
Cleared Mar 03, 2023
NIKKICART
K221652 · KPO
Renal Care Dialysis Solutions, S.A....
Gastroenterology & Urology · 269d
Cleared Mar 03, 2023
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
K221661 · DXC
Compression Works, Inc.
Cardiovascular · 268d
Cleared Mar 03, 2023
INJECTION PIN (KIP(02031-02061) (03031-03061))
K221697 · NDN
Slk Ortho, LLC
Orthopedic · 266d
Cleared Mar 03, 2023
Polypectomy Snare
K221713 · FDI
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 263d
Cleared Mar 03, 2023
Alinity m STI Assay
K222379 · QEP
Abbott Molecular, Inc.
Microbiology · 210d