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
5905–5928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2024
Imbio PHA (4.0.0)
K241847 · QIH
Imbio, Inc.
Radiology · 65d
Cleared Aug 30, 2024
ToxiSeal™ Vial Adaptor
K241823 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 67d
Cleared Aug 30, 2024
Ultrasound Transducer Cover
K241662 · ITX
Vitrolife Sweden AB
Radiology · 81d
Cleared Aug 30, 2024
Kingcera Dental Zirconia Blank
K241602 · EIH
Hunan Qinghao Puzhong Technology Co.,...
Dental · 87d
Cleared Aug 30, 2024
uMI Panorama
K241585 · KPS
Shanghai United Imaging Healthcare...
Radiology · 88d
Cleared Aug 30, 2024
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek...
K241583 · DPW
Remington Medical, Inc.
Cardiovascular · 88d
Cleared Aug 30, 2024
Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire)
K241518 · OBP
The Magstim Company Limited
Neurology · 93d
Cleared Aug 30, 2024
ODI-Tech
K241393 · MUD
Odi Medical AS
General & Plastic Surgery · 106d
Cleared Aug 30, 2024
Heyman Packing Applicator Set (GM11004580)
K241386 · JAQ
Varian Medical Systems, Inc.
Radiology · 107d
Cleared Aug 30, 2024
Cadence Ankle PSI System
K241326 · OYK
3D Systems, Inc.
Orthopedic · 112d
Cleared Aug 30, 2024
Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
K241318 · MUJ
Adaptiiv Medical Technologies, Inc.
Radiology · 112d
Cleared Aug 30, 2024
JetBoots PRO Plus
K241256 · IRP
Therabody, Inc.
Physical Medicine · 116d
Cleared Aug 30, 2024
Salto Talaris Ankle PSI System
K241148 · OYK
3D Systems, Inc.
Orthopedic · 127d
Cleared Aug 30, 2024
Vave Wireless Ultrasound System
K241051 · IYN
Vave Health, Inc.
Radiology · 135d
Cleared Aug 30, 2024
WallFlex Biliary RX Stent System
K240464 · FGE
Boston Scientific
Gastroenterology & Urology · 196d
Cleared Aug 30, 2024
Orthopeasia Spinal Fixation System
K240180 · NKB
Orthopeasia Co., Ltd.
Orthopedic · 220d
Cleared Aug 30, 2024
Velmeni for Dentists (V4D)
K240003 · MYN
Velmeni, Inc.
Radiology · 241d
Cleared Aug 30, 2024
embecta Insulin Delivery System
K234027 · QFG
Embecta Medical I, LLC
Chemistry · 254d
Cleared Aug 30, 2024
Alinity i Toxo IgM
K233932 · LGD
Abbott Laboratories
Microbiology · 260d
Cleared Aug 30, 2024
Daylight
K233872 · SCP
Big Health, Inc.
Neurology · 267d
Cleared Aug 30, 2024
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
K233107 · OWB
Canon Medical Systems Corporation
Radiology · 338d
Cleared Aug 30, 2024
Unipro (K-UNIPRO-US)
K232441 · GZJ
Tenscare, Ltd.
Neurology · 382d
Cleared Aug 30, 2024
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
K231969 · HGX
Dongguanshi Yiyingmei Technology Co.,...
Obstetrics & Gynecology · 424d
Cleared Aug 29, 2024
Grass® MR Conditional/CT Cup Electrodes
K242346 · GXY
Natus Manufacturing Limited
Neurology · 22d