Search FDA 510(k) Database

6,718 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
12457–12480 of 174,061
Cleared May 06, 2022
Elecsys Testosterone II
K211685 · CDZ
Roche Diagnostics
Chemistry · 338d
Cleared May 06, 2022
Segment 3DPrint
K211966 · LLZ
Medviso AB
Radiology · 316d
Cleared May 06, 2022
Portable Folding Electric Wheelchair (Model: DC01)
K212092 · ITI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 304d
Cleared May 06, 2022
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar...
K212289 · QCI
Neuronetics, Inc.
Neurology · 289d
Cleared May 06, 2022
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft...
K212555 · DQA
Covidien, LLC
Anesthesiology · 266d
Cleared May 06, 2022
Electric Breast Pump
K212564 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 266d
Cleared May 06, 2022
SpyGlass Discover Balloon Dilation Catheter
K212582 · GCA
Boston Scientific Corporation
Gastroenterology & Urology · 263d
Cleared May 06, 2022
Quantum Heater-Cooler
K212657 · DWC
Spectrum Medical , Ltd.
Cardiovascular · 256d
Cleared May 06, 2022
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
K213788 · NUH
Dongguan Bohuikang Technology Co.,Ltd
Neurology · 151d
Cleared May 06, 2022
Disposable EEG cable
K213884 · GXY
Shenzhen Changke Connect Electronics...
Neurology · 144d
Cleared May 06, 2022
WAVi SCAN EEG System and Accessories
K213900 · GWQ
Wavi Co.
Neurology · 143d
Cleared May 06, 2022
PISCES-SA Standalone ALIF Interbody System
K213935 · OVD
Osseus Fusion Systems
Orthopedic · 141d
Cleared May 06, 2022
KEOPS Balance Analyzer 3D
K213975 · LLZ
S.M.A.I.O
Radiology · 137d
Cleared May 06, 2022
Masimo O3 Regional Oximeter System
K214072 · MUD
Masimo Corporation
General & Plastic Surgery · 130d
Cleared May 06, 2022
Medline Orbis Chemo Surgical Gown
K214108 · FYA
Medline Industries, LP
General Hospital · 128d
Cleared May 06, 2022
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia...
K220110 · DTR
Qura S.R.L
Cardiovascular · 113d
Cleared May 06, 2022
HM70 EVO Diagnostic Ultrasound System
K220269 · IYN
Samsung Medison Co., Ltd.
Radiology · 95d
Cleared May 06, 2022
Astroglide Glycerin & Paraben Free
K220653 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 60d
Cleared May 06, 2022
NewTom 7G
K220664 · JAK
Cefla S.C.
Radiology · 60d
Cleared May 06, 2022
Vatech Clismile
K220689 · NJM
Rayence Co., Ltd.
Dental · 58d
Cleared May 06, 2022
Invu by Nuvo
K221046 · LQK
Nuvo- Group , Ltd.
Obstetrics & Gynecology · 28d
Cleared May 05, 2022
PosiSep EAR Fragmentable Ear Dressing
K210411 · NHB
Hemostasis, LLC
Ear, Nose, Throat · 448d
Cleared May 05, 2022
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1,...
K210565 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 434d
Cleared May 05, 2022
NAVIRFA Scope
K211529 · IYO
Navifus Corporation
Radiology · 353d