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
10105–10128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 2023
ClariVy™ Cervical IBF System
K230414 · ODP
Vy Spine, LLC
Orthopedic · 85d
Cleared May 12, 2023
EUROSCREW NG
K230394 · MAI
Teknimed
Orthopedic · 87d
Cleared May 12, 2023
PMMA BLOCK
K223706 · EBG
Huliang(Shanghai) Bio-Tech Co., Ltd.
Dental · 151d
Cleared May 12, 2023
BD Secondary Infusion Set
K223101 · FPA
Care Fusion
General Hospital · 224d
Cleared May 12, 2023
iTFlow
K222854 · LLZ
Cardio Flow Design, Inc.
Radiology · 233d
Cleared May 12, 2023
Harvest Printable Resin
K222489 · EBI
Harvest Dental Products, LLC
Dental · 268d
Cleared May 12, 2023
Intraoperative Ultrasound Probe Cover
K222460 · ITX
Exact Medical Manufacturing
Radiology · 270d
Cleared May 12, 2023
Waypoint GPS
K222106 · QWP
Waypoint Orthopedics, Inc.
Neurology · 298d
Cleared May 12, 2023
IU Implant System Abutment
K221969 · NHA
Warantec Co., Ltd.
Dental · 311d
Cleared May 11, 2023
ExacTrac Dynamic 1.1.2
K231052 · IYE
Brainlab AG
Radiology · 28d
Cleared May 11, 2023
JAWS Nitinol Staple System
K230550 · JDR
Paragon 28, Inc.
Orthopedic · 72d
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
SubtleMR (2.3.x)
K223623 · LLZ
Subtle Medical, Inc.
Radiology · 157d
Cleared May 11, 2023
CryoX Vitrification Freeze Kit / Thaw Kit
K223265 · MQL
Zhejiang Horizon Medical Technology...
Obstetrics & Gynecology · 199d
Cleared May 11, 2023
OpenTex
K222549 · NPK
Purgo Biologics, Inc.
Dental · 261d
Cleared May 11, 2023
Regeneten Bioinductive Implant
K222501 · OWY
Smith and Nephew, Inc.
Orthopedic · 266d
Cleared May 11, 2023
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL...
K220721 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 423d
Cleared May 10, 2023
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
K231338 · LBH
3M Espe Dental Products
Dental · 2d
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
HandX™ Monopolar Scissors
K230491 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 76d
Cleared May 10, 2023
Emerald Herbst
K223624 · LRK
Island Dental Lab, Inc Dba Emerald...
Dental · 156d
Cleared May 10, 2023
Internal Joint Stabilizer - Elbow
K223318 · OZI
Skeletal Dynamics, Inc.
Orthopedic · 194d
Cleared May 10, 2023
Digital Thermometer (Model QT001)
K223044 · FLL
Shen Zhen Rong Feng Technology Co., Ltd.
General Hospital · 223d
Cleared May 10, 2023
Akunah REFLECT
K222987 · LLZ
Akunah Pty, Ltd.
Radiology · 224d