Search FDA 510(k) Database

Cleared Oct 24, 2020

Li-Battery powered OTC TENS/EMS Combination Stimulator

K201335 · NUH

Everyway Medical Instruments Co.,Ltd

Neurology · 157d

Cleared Oct 23, 2020

Planmed Clarity 2D and Clarity S

K192317 · MUE

Planmed OY

Radiology · 424d

Cleared Oct 23, 2020

BenestaTM Tissue Removal Device

K192811 · HIH

Caldera Medical, Inc.

Obstetrics & Gynecology · 389d

Cleared Oct 23, 2020

MaxZero Extension Sets with Needle-Free Connector(s)

K193088 · FPA

Carefusion, Inc.

General Hospital · 352d

Cleared Oct 23, 2020

V-Mix

K193357 · KJJ

Inter-Med/Vista Dental Products

Dental · 324d

Cleared Oct 23, 2020

Cryocheck Hex LA

K193556 · GFO

Precision Biologic

Hematology · 305d

Cleared Oct 23, 2020

OXY-1 System

K200109 · DTZ

Abiomed, Inc.

Cardiovascular · 280d

Cleared Oct 23, 2020

PocketDoc™ Micro Wound Therapy System

K200223 · OMP

Pensar Medical, LLC

General & Plastic Surgery · 268d

Cleared Oct 23, 2020

Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA,...

K200249 · MQL

Kitazato Corporation

Obstetrics & Gynecology · 263d

Cleared Oct 23, 2020

Nerivio

K201824 · QGT

Theranica Bio-Electronics, Ltd.

Neurology · 114d

Cleared Oct 23, 2020

Infrared ear and forehead thermometer, model YI-100

K201843 · FLL

Wenzhou Yosun Medical Technology Co.,Ltd

General Hospital · 109d

Cleared Oct 23, 2020

SURGIPHOR Wound Irrigation System

K202071 · FQH

Orthophor, LLC

General & Plastic Surgery · 88d

Cleared Oct 23, 2020

SIR-Spheres Microspheres Activity Calculator (SMAC)

K202392 · KPS

Sirtex Medical US Holdings, Inc.

Radiology · 63d

Cleared Oct 23, 2020

Mobio Total Knee System

K202429 · JWH

B-One Ortho, Corp.

Orthopedic · 59d

Cleared Oct 23, 2020

Drakon and Sequre Microcatheters

K202797 · DQO

Accurate Medical Therapeutics, Ltd.

Cardiovascular · 30d

Cleared Oct 23, 2020

Wiltrom Spinal Fixation System

K202894 · NKB

Wiltrom Corporation Limited

Orthopedic · 25d

Cleared Oct 22, 2020

DIOnavi-Denture

K193623 · EBI

Dio Corporation

Dental · 301d

Cleared Oct 22, 2020

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N...

K200318 · ERL

KARL STORZ Endoscopy-America, Inc.

Ear, Nose, Throat · 258d

Cleared Oct 22, 2020

Voluson E10

K201768 · IYN

Ge Healthcare

Radiology · 115d

Cleared Oct 22, 2020

Broncoflex Agile

K202180 · EOQ

Axess Vision Technology

Ear, Nose, Throat · 79d

Cleared Oct 22, 2020

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

K202428 · GEX

Lumenis, Ltd.

General & Plastic Surgery · 58d

Cleared Oct 22, 2020

GEO Bone Screw System

K202817 · HWC

Gramercy Extremity Orthopedics, LLC

Orthopedic · 28d

Cleared Oct 22, 2020

EzOrtho

K202948 · LLZ

Ewoosoft Co., Ltd.

Radiology · 22d

Cleared Oct 21, 2020

C4 Fiducial Marker

K192771 · NEU

C4 Imaging, LLC

General & Plastic Surgery · 387d