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
7201–7224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2024
SF Push- in Anchor
K240288 · MAI
Surgical Fusion Technologies GmbH
Orthopedic · 60d
Cleared Apr 01, 2024
EVOLUTION® Hinge Knee System
K240043 · KRO
Microport Orthopedics, Inc.
Orthopedic · 87d
Cleared Apr 01, 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs...
K233990 · LZA
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 105d
Cleared Apr 01, 2024
Us2.v2
K233676 · QIH
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Radiology · 137d
Cleared Apr 01, 2024
Talis EMR with Talis +ACG (Talis EMR with +ACG)
K233133 · MWI
Talis Clinical, LLC
Cardiovascular · 187d
Cleared Apr 01, 2024
External Hex Implant System
K232726 · DZE
Southern Implants (Pty), Ltd.
Dental · 208d
Cleared Apr 01, 2024
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO
K230895 · EBW
Cefla S.C.
Dental · 367d
Cleared Mar 30, 2024
Rejoyn
K231209 · SAP
Otsuka America Pharmaceutical, Inc.
Neurology · 338d
Cleared Mar 29, 2024
MAGNETOM Viato.Mobile
K240608 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Mar 29, 2024
SmoothSkin Pure Unplugged (SSB3)
K240587 · OHT
Cyden Limited
General & Plastic Surgery · 28d
Cleared Mar 29, 2024
LCD Monitors C310S, G310S, C316S, G316S, C616W
K240310 · PGY
Shenzhen Beacon Display Technology...
Radiology · 56d
Cleared Mar 29, 2024
AlignRT Plus
K233622 · IYE
Vision Rt, Ltd.
Radiology · 137d
Cleared Mar 29, 2024
Genesys Spine Sacroiliac Joint Fusion System with Navigation
K233595 · OLO
Genesys Spine
Orthopedic · 142d
Cleared Mar 29, 2024
AVIEW CAC
K233211 · QIH
Coreline Soft Co., Ltd.
Radiology · 183d
Cleared Mar 29, 2024
Disposable Surgical Gown
K233068 · FYA
Nanning Tecbod Biological Technology...
General Hospital · 185d
Cleared Mar 29, 2024
Disposable Sphincterotome
K232825 · KNS
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 198d
Cleared Mar 29, 2024
LUNA 3D
K232031 · IYE
Lap GmbH Laser Applikationen
Radiology · 266d
Cleared Mar 29, 2024
Citrated: K, KH, RTH, FFH
K232018 · JPA
Haemonetics Corporation
Hematology · 266d
Cleared Mar 29, 2024
Dose IQ Safety Software
K230665 · PHC
Baxter Healthcare Corporation
General Hospital · 385d
Cleared Mar 29, 2024
Novum IQ Large Volume Pump
K211122 · FRN
Baxter Healthcare Corporation
General Hospital · 1079d
Cleared Mar 28, 2024
LINQ II™ Insertable Cardiac Monitor (ICM)
K240693 · MXD
Medtronic, Inc.
Cardiovascular · 15d
Cleared Mar 28, 2024
CustomizedBone Service
K240567 · GXN
Fin-Ceramica Faenza S.P.A.
Neurology · 28d
Cleared Mar 28, 2024
InstaStrip Fentanyl Rapid Test (Urine)
K240295 · NGL
Instanosis, Inc.
Toxicology · 56d
Cleared Mar 28, 2024
Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G,...
K240284 · IZL
Shenzhen Browiner Tech Co., Ltd.
Radiology · 56d