FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
15193–15216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2022
High Retention Attachment System
K213391 · NHA
Zest Anchors, LLC
Dental · 88d
Cleared Jan 11, 2022
Esteya
K213942 · JAD
Nucletron B.V.
Radiology · 25d
Cleared Jan 10, 2022
Sheng Jing Tang Surgical Mask
K211260 · FXX
Liaoning Shengjingtang Biotechnology...
General Hospital · 259d
Cleared Jan 10, 2022
iQ 2 Nasal Mask, Phantom 2 Nasal Mask
K211274 · BZD
Sleepnet Corporation
Anesthesiology · 258d
Cleared Jan 10, 2022
Gingi-Aid Gel
K211419 · MVL
Belport Company, Inc., Gingi-Pak
Dental · 248d
Cleared Jan 10, 2022
Romero Cervical Cage
K212358 · OVE
Spineup, Inc.
Orthopedic · 165d
Cleared Jan 10, 2022
DUMI ManipulatOR
K212505 · LKF
The O R Company Pty, Ltd.
Obstetrics & Gynecology · 154d
Cleared Jan 10, 2022
3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix
K212541 · EBI
Deltamed GmbH
Dental · 151d
Cleared Jan 10, 2022
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat...
K212688 · DTR
Qura S.R.L
Cardiovascular · 138d
Cleared Jan 10, 2022
Powered Wheelchair
K212854 · ITI
Zhejiang Qianxi Vehicle Co., Ltd.
Physical Medicine · 124d
Cleared Jan 10, 2022
G-Tech Wireless Patch System (WPS)
K212954 · MYE
G-Tech Medical
Gastroenterology & Urology · 116d
Cleared Jan 10, 2022
MagnetOs granules
K213111 · MQV
Kuros Biosciences B.V
Orthopedic · 108d
Cleared Jan 09, 2022
Powder Free Nitrile Examination Gloves, Blue Chemotest
K211666 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 222d
Cleared Jan 09, 2022
Powder free nitrile examination glove- black, non sterile
K212801 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 129d
Cleared Jan 07, 2022
EK Implants and Abutments System
K203360 · DZE
Hiossen, Inc.
Dental · 417d
Cleared Jan 07, 2022
CORE1 Implant System
K210039 · DZE
Cybermed, Inc.
Dental · 366d
Cleared Jan 07, 2022
GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6...
K210198 · HRS
Gpc Medical Limited
Orthopedic · 347d
Cleared Jan 07, 2022
Infrared Thermometer
K210564 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 316d
Cleared Jan 07, 2022
Agile Devices Angler Steerable, Deflectable Microcatheter
K211110 · KRA
Agile Devices, Inc.
Cardiovascular · 268d
Cleared Jan 07, 2022
Visualase MRI-Guided Laser Ablation System (SW 3.4)
K211269 · ONO
Medtronic Navigation, Inc.
Neurology · 255d
Cleared Jan 07, 2022
Selebrek PTCA Balloon Dilatation Catheter
K211349 · LOX
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 249d
Cleared Jan 07, 2022
AIBOLIT 3D+
K211443 · LLZ
Aibolit Technologies, LLC
Radiology · 242d
Cleared Jan 07, 2022
DropSafe Safety Pen Needles
K211716 · FMI
Htl Strefa SA
General Hospital · 218d
Cleared Jan 07, 2022
SignaSure Dual Mobility System
K211742 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 214d