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
9889–9912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2023
A-Line Advanced
K231635 · NJM
Biocetec Co., Ltd.
Dental · 1d
Cleared Jun 06, 2023
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With...
K231349 · LZA
Nephron Nitrile, LLC
General Hospital · 28d
Cleared Jun 06, 2023
AviClear Laser System
K230660 · GEX
Cutera, Inc.
General & Plastic Surgery · 88d
Cleared Jun 06, 2023
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
K230584 · OWQ
Vein 360, LLC
Cardiovascular · 96d
Cleared Jun 06, 2023
F3D Interbody System
K230329 · ODP
Corelink, LLC
Orthopedic · 120d
Cleared Jun 06, 2023
Gnesis EMS Plus
K230261 · NGX
Creative Fitness Developments S.L.
Physical Medicine · 126d
Cleared Jun 06, 2023
Pantheris LV Atherectomy Catheter
K230005 · MCW
Avinger, Inc.
Cardiovascular · 154d
Cleared Jun 06, 2023
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
K223855 · QIH
Feops NV
Radiology · 165d
Cleared Jun 06, 2023
Olea S.I.A. Neurovascular V1.0
K223532 · LLZ
Olea Medical
Radiology · 195d
Cleared Jun 06, 2023
ARC Intensive Care Information System (ARC System)
K220117 · MWI
Ordinatrum Solutions
Cardiovascular · 508d
Cleared Jun 06, 2023
Diode laser therapy device
K212734 · GEX
Triangel Rsd Limited
General & Plastic Surgery · 645d
Cleared Jun 06, 2023
Diode laser therapy device
K212733 · GEX
Beijing Star New Tech Co., Ltd.
General & Plastic Surgery · 645d
Cleared Jun 05, 2023
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
K231348 · QSE
Roche Diagnostics
Immunology · 27d
Cleared Jun 05, 2023
Zhenjiang Assure Mechanical Wheelchair,model:K1
K231320 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 28d
Cleared Jun 05, 2023
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
K230937 · DHA
Abbott Laboratories
Chemistry · 63d
Cleared Jun 05, 2023
SPY Portable Handheld Imaging (SPY-PHI) System
K230727 · IZI
Novadaq Technologies Ulc (A Part of...
General & Plastic Surgery · 81d
Cleared Jun 05, 2023
APOLLO ADVANTAGE Nitrile Examination Gloves
K230633 · LZA
Dell Corning Corporation
General Hospital · 90d
Cleared Jun 05, 2023
ArtiSential Laparoscopic Instruments-Electrodes
K230498 · GEI
Livsmed, Inc.
General & Plastic Surgery · 101d
Cleared Jun 05, 2023
DynaFlex Clear Brackets & Buttons
K230225 · NJM
Dyna Flex
Dental · 129d
Cleared Jun 05, 2023
FX V135(TM) Shoulder Prosthesis
K223801 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 168d
Cleared Jun 05, 2023
HandX™ Self-Righting Needle Holder
K223718 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 175d
Cleared Jun 05, 2023
Fluido Compact Blood and Fluid Warming System
K211618 · LGZ
The Surgical Company International B.V.
General Hospital · 740d
Cleared Jun 04, 2023
Stella
K221752 · DZE
Shinhung Mst Co., Ltd.
Dental · 353d
Cleared Jun 02, 2023
Fine Osteotomy™
K231314 · PBF
Bodycad Laboratories, Inc.
Orthopedic · 28d