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
10393–10416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 2023
SubtleMR (2.3.x)
K223623 · LLZ
Subtle Medical, Inc.
Radiology · 157d
Cleared May 11, 2023
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
K230280 · KTI
Ga Health Company Limited
Ear, Nose, Throat · 99d
Cleared May 11, 2023
JAWS Nitinol Staple System
K230550 · JDR
Paragon 28, Inc.
Orthopedic · 72d
Cleared May 11, 2023
ExacTrac Dynamic 1.1.2
K231052 · IYE
Brainlab AG
Radiology · 28d
Cleared May 10, 2023
Neurophet AQUA
K220437 · LLZ
Neurophet., Inc.
Radiology · 448d
Cleared May 10, 2023
Sientra, inc. Portfinder
K221127 · LCJ
Sientra, Inc.
General & Plastic Surgery · 387d
Cleared May 10, 2023
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032,...
K222870 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 230d
Cleared May 10, 2023
Akunah REFLECT
K222987 · LLZ
Akunah Pty, Ltd.
Radiology · 224d
Cleared May 10, 2023
Digital Thermometer (Model QT001)
K223044 · FLL
Shen Zhen Rong Feng Technology Co., Ltd.
General Hospital · 223d
Cleared May 10, 2023
Internal Joint Stabilizer - Elbow
K223318 · OZI
Skeletal Dynamics, Inc.
Orthopedic · 194d
Cleared May 10, 2023
Emerald Herbst
K223624 · LRK
Island Dental Lab, Inc Dba Emerald...
Dental · 156d
Cleared May 10, 2023
HandX™ Monopolar Scissors
K230491 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 76d
Cleared May 10, 2023
AMP by Method Mobility, AMP Plus (or +) by Method Mobility
K231032 · ITI
Method Mobility
Physical Medicine · 29d
Cleared May 10, 2023
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
K231338 · LBH
3M Espe Dental Products
Dental · 2d
Cleared May 09, 2023
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for...
K212857 · FMF
Jiangsu Zhiyu Medical Instrument Co,...
General Hospital · 608d
Cleared May 09, 2023
Latitud™ Hip Replacement System
K222436 · LPH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 270d
Cleared May 09, 2023
Retitrack
K222484 · HLL
C. Light Technologies, Inc.
Ophthalmic · 265d
Cleared May 09, 2023
CX50N
K222719 · PGY
Wide Corporation
Radiology · 243d
Cleared May 09, 2023
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
K223015 · MLR
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators...
K223023 · FRC
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
Tyvek Roll with CI for STERLINK Sterilizer
K223025 · FRG
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
SIRION Lateral Lumbar Interbody System
K223335 · MAX
Astura Medical
Orthopedic · 189d
Cleared May 09, 2023
Catalyst R1 Reverse Shoulder System
K223655 · PHX
Catalyst Orthoscience, Inc.
Orthopedic · 154d
Cleared May 09, 2023
Tens & Ems Device
K223825 · NUH
Shenzhen Jian Feng Electronic...
Physical Medicine · 139d