Search FDA 510(k) Database

Cleared Nov 20, 2020

Optimized Positioning System (OPS) Insight

K202805 · LLZ

Corin USA

Radiology · 58d

Cleared Nov 20, 2020

Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation...

K202962 · GEI

New Deantronics Taiwan , Ltd.

General & Plastic Surgery · 51d

Cleared Nov 20, 2020

Arthrex Eclipse Titanium Humeral Head

K203100 · PKC

Arthrex, Inc.

Orthopedic · 37d

Cleared Nov 20, 2020

DTX Studio Clinic

K203156 · LLZ

Nobel Biocare AB

Radiology · 29d

Cleared Nov 20, 2020

Revolution Ascend

K203169 · JAK

Ge Healthcare Japan Corporation

Radiology · 28d

Cleared Nov 20, 2020

Fortress Introducer Sheath System

K203179 · DYB

Contract Medical International, GmbH

Cardiovascular · 25d

Cleared Nov 19, 2020

GM501 Wash with Phenol Red and Gentamicin

K192503 · MQL

Hamilton Thorne Incorporated

Obstetrics & Gynecology · 434d

Cleared Nov 19, 2020

Sapphire Infusion Pump, Sapphire administration sets

K192860 · FRN

Q Core Medical , Ltd.

General Hospital · 412d

Cleared Nov 19, 2020

SMR TT Augmented Glenoid System

K200171 · PHX

Lima Corporate S.P.A.

Orthopedic · 301d

Cleared Nov 19, 2020

FotoDent denture

K200580 · EBI

Dreve Dentamid GmbH

Dental · 259d

Cleared Nov 19, 2020

K2 MOBILE

K200693 · GEX

Hulaser, Inc.

General & Plastic Surgery · 248d

Cleared Nov 19, 2020

Air Compression Therapy Device

K201694 · IRP

Shenzhen Dongjilian Electronics Co.,...

Physical Medicine · 150d

Cleared Nov 19, 2020

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with...

K201867 · FKX

Baxter Healthcare Corporation

Gastroenterology & Urology · 135d

Cleared Nov 19, 2020

StarWalker

K202172 · GEX

Fotona D.O.O.

General & Plastic Surgery · 108d

Cleared Nov 19, 2020

Carewear Firefly Wrinkle Reduction

K202442 · OHS

Carewear Corp.

General & Plastic Surgery · 85d

Cleared Nov 19, 2020

Laser Therapy Device

K202980 · GEX

Shenzhen Leaflife Technology Co., Ltd.

General & Plastic Surgery · 50d

Cleared Nov 19, 2020

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360...

K203008 · MCW

Cardiovascular Systems, Inc.

Cardiovascular · 49d

Cleared Nov 19, 2020

DePuy Corail AMT Hip Prosthesis

K203167 · LZO

DePuy Orthopaedics, Inc.

Orthopedic · 27d

Cleared Nov 18, 2020

Liebel-Flarsheim IBP Transfer Set

K193010 · PQH

Liebel-Flarsheim Company, LLC

General Hospital · 386d

Cleared Nov 18, 2020

Viveve System

K200472 · GEI

Viveve Medical, Inc.

General & Plastic Surgery · 266d

Cleared Nov 18, 2020

Freedom(R) - TiNbN Coated Knee

K200912 · JWH

Maxx Orthopedics, Inc.

Orthopedic · 226d

Cleared Nov 18, 2020

Genius AI Detection

K201019 · QDQ

Hologic, Inc.

Radiology · 215d

Cleared Nov 18, 2020

syngo.via MI Workflows, syngo MBF

K201195 · QIH

Siemens Medical Solutions USA, Inc.

Radiology · 198d

Cleared Nov 18, 2020

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy...

K201382 · OAS

De Gotzen S.R.L.

Radiology · 176d