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
11521–11544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 2022
Powder-Free Latex examination gloves
K222612 · LYY
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 87d
Cleared Nov 25, 2022
DentCare Aligners
K222918 · NXC
Dentcare Dental Lab Pvt , Ltd.
Dental · 60d
Cleared Nov 23, 2022
Closed System Transfer Device
K201460 · ONB
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 904d
Cleared Nov 23, 2022
Glenoid Reconstruction System
K213459 · PHX
Medacta International S.A.
Orthopedic · 392d
Cleared Nov 23, 2022
CuringPen Dental Curing Light
K221152 · EBZ
Changzhou Sifary Medical Technology...
Dental · 217d
Cleared Nov 23, 2022
PainShield MD PLUS
K221210 · PFW
Nanovibronix, Inc.
Physical Medicine · 210d
Cleared Nov 23, 2022
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De)
K221815 · GEI
Baisheng Medical Co., Ltd.
General & Plastic Surgery · 154d
Cleared Nov 23, 2022
Disposable Automatically Retractable Safety Syringes (with detachable needle)
K222452 · MEG
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 100d
Cleared Nov 23, 2022
EchoGo Heart Failure
K222463 · QUO
Ultromics Limited
Cardiovascular · 100d
Cleared Nov 23, 2022
Nitrile Patient Examination Glove
K222534 · LZA
Jiangxi Jiangxi Zhonghong Pulin...
General Hospital · 93d
Cleared Nov 23, 2022
Ai Ray Dental X-Ray Device
K222569 · EHD
Guilin Woodpecker Medical Instrument...
Radiology · 91d
Cleared Nov 23, 2022
LDE4 Lancing Device
K222656 · QRL
I-Sens, Inc.
General & Plastic Surgery · 82d
Cleared Nov 23, 2022
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics...
K222967 · HWC
Avanti Orthopaedics, Inc.
Orthopedic · 57d
Cleared Nov 23, 2022
Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
K223068 · FXX
Guangdong Golden Leaves Technology...
General Hospital · 54d
Cleared Nov 23, 2022
TempSure System
K223292 · GEI
Cynosure, LLC
General & Plastic Surgery · 28d
Cleared Nov 22, 2022
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
K211507 · FRF
Beiang Air Tech , Ltd.
General Hospital · 557d
Cleared Nov 22, 2022
Canady Flex RoboWrist
K212736 · GCJ
Us Medical Innovations, LLC
General & Plastic Surgery · 449d
Cleared Nov 22, 2022
PRIMED Pediatric Facemask
K213427 · OXZ
Primed Medical Products, Inc.
General Hospital · 397d
Cleared Nov 22, 2022
AccuCTP
K220663 · LLZ
ArteryFlow Technology Co., Ltd.
Radiology · 260d
Cleared Nov 22, 2022
WISE Cortical Strip (WCS)
K221123 · GYC
Wise S.R.L.
Neurology · 218d
Cleared Nov 22, 2022
EasyOne Filter
K221250 · CAH
Ndd Medizintechnik AG
General Hospital · 204d
Cleared Nov 22, 2022
ARIX Rib System
K221412 · HRS
Jeil Medical Corporation
Orthopedic · 190d
Cleared Nov 22, 2022
E3 and Profile
K221471 · GWE
Diagnosys, LLC
Ophthalmic · 186d
Cleared Nov 22, 2022
Minimally Invasive Prostate Surgery Navigation System
K221499 · LLZ
Augment Intelligent Medical System...
Radiology · 183d