Search FDA 510(k) Database

Cleared Nov 23, 2020

Invictus™ Spinal Fixation System

K203056 · NKB

Alphatec Spine, Inc.

Orthopedic · 46d

Cleared Nov 22, 2020

Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons /...

K202090 · KGO

Molnlycke Health Care Us, LLC

General Hospital · 117d

Cleared Nov 20, 2020

Puritan Bennett 980 Series Ventilator System

K193056 · CBK

Covidien, LLC

Anesthesiology · 385d

Cleared Nov 20, 2020

MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag

K193191 · BTL

Weinmann Emergency Medical Technology...

Anesthesiology · 367d

Cleared Nov 20, 2020

V-ONESTEP

K193285 · MQL

Vitromed GmbH

Obstetrics & Gynecology · 359d

Cleared Nov 20, 2020

CorInsights MRI

K193287 · LLZ

Adm Diagnostics, Inc.

Radiology · 359d

Cleared Nov 20, 2020

Codman Surgical Patties & Strips

K193346 · HBA

Integra LifeSciences Corporation

Neurology · 353d

Cleared Nov 20, 2020

Solitaire Platinum Revascularization Device, Solitaire X Revascularization...

K193576 · POL

Micro Therapeutics, Inc. d/b/a ev3...

Neurology · 333d

Cleared Nov 20, 2020

HALO

K200873 · QAS

Nico-Lab B.V.

Radiology · 233d

Cleared Nov 20, 2020

NeuroStar Advanced Therapy

K201158 · OBP

Neuronetics, Inc.

Neurology · 204d

Cleared Nov 20, 2020

Optomed Smartscope M5 with Optomed Smartscope FA

K201325 · HKI

Optomed Oyj

Ophthalmic · 186d

Cleared Nov 20, 2020

Passio Pump Drainage System

K201404 · DWM

Bearpac Medical

Anesthesiology · 176d

Cleared Nov 20, 2020

TIPCAM1 Rubina Video Endoscope System

K201526 · GCJ

Karl Storz Endoscopy America

Obstetrics & Gynecology · 165d

Cleared Nov 20, 2020

Dornier MAGELLAN Ureteral Access Sheath

K201815 · FED

Dornier Medtech America, Inc.

Gastroenterology & Urology · 142d

Cleared Nov 20, 2020

MiniCAT 2D

K201825 · KPR

Xoran Technologies, LLC

Radiology · 141d

Cleared Nov 20, 2020

MPS 3 ND Myocardial Protection System

K201984 · DTR

Quest Medical, Inc.

Cardiovascular · 126d

Cleared Nov 20, 2020

Silatrix Oral Gel

K202000 · OLR

Sa3, LLC

General & Plastic Surgery · 123d

Cleared Nov 20, 2020

Vscan Air

K202035 · ITX

GE Medical Systems Ultrasound and...

Radiology · 120d

Cleared Nov 20, 2020

Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter

K202042 · OWQ

Innovative Health, LLC

Cardiovascular · 120d

Cleared Nov 20, 2020

Medical surgical mask

K202139 · FXX

Guangdong Kingfa Sci. & Tech.Co., Ltd.

General Hospital · 112d

Cleared Nov 20, 2020

FilmArray Global Fever Panel External Control Kit

K202382 · PMN

Biofire Defense, LLC

Microbiology · 92d

Cleared Nov 20, 2020

LC ResinCal PC

K202413 · EJK

S&C Polymer Silicon- Und Composite...

Dental · 88d

Cleared Nov 20, 2020

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device...

K202529 · LRK

Prosomnus Sleep Technologies, Inc.

Dental · 80d

Cleared Nov 20, 2020

Ortho Solutions Plating System

K202764 · HRS

Ortho Solutions UK , Ltd.

Orthopedic · 60d