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: 2023–2023 ×
3,347 results
3265–3288 of 3,347
Search insights Median review: 139d Cleared: 99% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Orthopedic
Cleared Jan 13, 2023
Access Testosterone
K223405 · CDZ
Beckman Coulter, Inc.
Chemistry · 65d
Cleared Jan 13, 2023
Non-Sterile Powder Free Nitrile Examination Gloves
K223221 · LZA
Dynacare Sdn Bhd
General Hospital · 88d
Cleared Jan 13, 2023
Light-Guide Cables
K223183 · HBI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 93d
Cleared Jan 13, 2023
Vibrant System
K223031 · QTN
Vibrant, Ltd.
Gastroenterology & Urology · 106d
Cleared Jan 13, 2023
s-Clean Link Abutment
K222913 · NHA
Dentis Co., Ltd.
Dental · 109d
Cleared Jan 13, 2023
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199
K222782 · HGX
Zhejiang Carebao Co., Ltd.
Obstetrics & Gynecology · 120d
Cleared Jan 13, 2023
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0,...
K222171 · OBP
Magstim Company, Ltd.
Neurology · 176d
Cleared Jan 13, 2023
Power Acute Triple Lumen Hemodialysis Catheter
K222170 · NIE
Health Line International Corporation
Gastroenterology & Urology · 176d
Cleared Jan 13, 2023
MONTAGE Settable, Resorbable Bone Putty
K221933 · GXP
Orthocon, Inc.
Neurology · 196d
Cleared Jan 13, 2023
Antimicrobial gauze sponge dressing
K221755 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 211d
Cleared Jan 13, 2023
Ideal Med Pro 3-Ply Disposable Face Mask
K221682 · FXX
Jsn Holdings, LLC
General Hospital · 217d
Cleared Jan 13, 2023
Galileo Vertebral Body Replacement Device
K221542 · PLR
Bright Spine
Orthopedic · 231d
Cleared Jan 13, 2023
S-Mono
K221317 · DZE
Shinhung Mst Co., Ltd.
Dental · 252d
Cleared Jan 13, 2023
Scivita 4KINSIGHT ICG Imaging System
K221252 · GCJ
Scivita Medical Technology Co., Ltd.
General & Plastic Surgery · 256d
Cleared Jan 13, 2023
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F,...
K221020 · EZL
Potrero Medical, Inc.
Gastroenterology & Urology · 282d
Cleared Jan 13, 2023
SignaSure Dual Mobility System
K220495 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 325d
Cleared Jan 13, 2023
Silk’n Toothwave
K214078 · QMJ
Home Skinovations , Ltd.
Dental · 382d
Cleared Jan 13, 2023
Spectricept Skin and Wound Cleanser
K213514 · FRO
Spectrum Antimicrobials, Inc....
General & Plastic Surgery · 437d
Cleared Jan 12, 2023
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD...
K223782 · EOQ
Ambu A/S
Ear, Nose, Throat · 27d
Cleared Jan 12, 2023
NuVasive Modulus-C Interbody System
K223731 · ODP
Nuvasive, Inc.
Orthopedic · 30d
Cleared Jan 12, 2023
Neuronaute with IceCap 2 & IceCap 2 Small
K223644 · GWQ
Bioserenity
Neurology · 37d
Cleared Jan 12, 2023
MAMMOVISTA B.smart (VB70)
K223363 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Jan 12, 2023
MU System
K222976 · NHA
Dentis Co., Ltd.
Dental · 106d
Cleared Jan 12, 2023
Rainbow 360
K222830 · KLE
Kerr Corporation
Dental · 115d