Search FDA 510(k) Database

6,797 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: Cleared only ×
174,061 results
13993–14016 of 174,061
Cleared Nov 09, 2021
WHILL Model C2
K213383 · ITI
Whill, Inc.
Physical Medicine · 27d
Cleared Nov 08, 2021
Highspeed Airturbine Handpiece
K202371 · EFB
Beijing Dongbo Dental Handpiece Co.,...
Dental · 446d
Cleared Nov 08, 2021
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen...
K203067 · DWF
Qura S.R.L
Cardiovascular · 395d
Cleared Nov 08, 2021
ST AIA-PACK BNP Assay
K211199 · NBC
Tosoh Bioscience, Inc.
Chemistry · 200d
Cleared Nov 08, 2021
GIQuant
K211356 · LLZ
Motilent, Ltd.
Radiology · 189d
Cleared Nov 08, 2021
Biotech Dental Kits
K212068 · KCT
Biotech Dental, Sas
General Hospital · 129d
Cleared Nov 08, 2021
Hura CTP v1.0
K212550 · LLZ
Hura Imaging, Inc.
Radiology · 87d
Cleared Nov 08, 2021
GT5 conductive & abrasive gel
K212787 · GYB
Wuhan Greentek Pty , Ltd.
Neurology · 68d
Cleared Nov 08, 2021
Paragon 28 External Ring Fixation System
K212895 · KTT
Paragon 28, Inc.
Orthopedic · 59d
Cleared Nov 08, 2021
FDR Cross (DR-XD 3000)
K212956 · OWB
Fujifilm Corporation
Radiology · 53d
Cleared Nov 07, 2021
Isolation Gown AAMI Level 3
K212504 · FYC
Kenpax International Limited
General Hospital · 90d
Cleared Nov 07, 2021
Medical Examination Gloves (Tested for Use with Chemotherapy)
K212506 · LZA
Guangdong Gymda Medical Technology...
General Hospital · 90d
Cleared Nov 05, 2021
MStim Drop Model: LGT-233
K202110 · GZI
Guangzhou Longest Science &...
Neurology · 463d
Cleared Nov 05, 2021
Disposable Medical Face Mask
K202676 · FXX
Zhejiang Senhong Medical&Instrument...
General Hospital · 416d
Cleared Nov 05, 2021
Best Glove-Latex Powder Free Examination Glove
K210253 · LYY
Bestsafe Glove Co., Ltd.
General Hospital · 280d
Cleared Nov 05, 2021
NextAR™ Spine Platform
K210859 · SBF
Medacta International S.A.
Orthopedic · 227d
Cleared Nov 05, 2021
Microcurrent device (Model: HBR2-1)
K211055 · NFO
Shenzhen DJ Medical Equipment Co., Ltd.
Neurology · 210d
Cleared Nov 05, 2021
SoftFix Balloon Trocar
K211577 · GCJ
Unimax Medical Systems, Inc.
General & Plastic Surgery · 168d
Cleared Nov 05, 2021
Acuson SC2000 Diagnostic Ultrasound System
K211726 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 154d
Cleared Nov 05, 2021
Anterion
K211817 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 147d
Cleared Nov 05, 2021
Drug Relief v1
K211971 · PZR
Dyansys, Inc.
Neurology · 134d
Cleared Nov 05, 2021
TrueLok Evo
K212044 · KTT
Orthofix Srl
Orthopedic · 128d
Cleared Nov 05, 2021
Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
K212460 · FXX
Guangzhou Zhengkang Medical Equipment...
General Hospital · 92d
Cleared Nov 05, 2021
Disposable Nitrile Examination gloves
K212485 · LZA
Fujian Yuanxin Safety Protection...
General Hospital · 88d