Search FDA 510(k) Database

Cleared Dec 03, 2020

NuVasive ACP System

K203253 · KWQ

Nu Vasive, Incorporated

Orthopedic · 29d

Cleared Dec 03, 2020

LineSider™ Spinal System

K203367 · NKB

Integrity Implants, Inc.

Orthopedic · 17d

Cleared Dec 02, 2020

Planmeca Romexis

K200572 · LLZ

Planmeca Oy

Radiology · 272d

Cleared Dec 02, 2020

NuVasive Navigation.S Instruments

K200719 · OLO

Nu Vasive, Incorporated

Orthopedic · 258d

Cleared Dec 02, 2020

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161

K201072 · KYI

Ensemble Orthopedics, LLC

Orthopedic · 224d

Cleared Dec 02, 2020

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device

K202270 · KCT

K1 Medical, LLC

General Hospital · 113d

Cleared Dec 02, 2020

Palm Care Blue Nitrile Examination Gloves Powder Free

K202384 · LZA

Hi-Care Thai Gloves Co. , Ltd.

General Hospital · 104d

Cleared Dec 02, 2020

WAVICIDE-OPA MEC Indicator

K202565 · JOJ

Serim Research Corporation

General Hospital · 89d

Cleared Dec 02, 2020

Auryon Atherectomy System

K202835 · MCW

Eximo Medical, Ltd.

Cardiovascular · 68d

Cleared Dec 02, 2020

SMS Cementless Stem

K203041 · LZO

Medacta International S.A.

Orthopedic · 57d

Cleared Dec 02, 2020

Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit...

K203053 · LNH

Canon Medical Systems Corporation

Radiology · 56d

Cleared Dec 02, 2020

Lux 35 Detector

K203159 · MQB

Carestream Health

Radiology · 40d

Cleared Dec 01, 2020

SLIMUS

K192970 · PKT

Hironic Co., Ltd.

General & Plastic Surgery · 405d

Cleared Dec 01, 2020

AcQMap High Resolution Imaging and Mapping System

K201015 · DQK

Acutus Medical, Inc.

Cardiovascular · 228d

Cleared Dec 01, 2020

Z5-TL

K201712 · DZE

Z-Systems AG

Dental · 161d

Cleared Dec 01, 2020

BASE4 Disposable Medical Mask

K202069 · FXX

Base4 Group, Inc.

General Hospital · 127d

Cleared Dec 01, 2020

Palm Care Latex Examination Powder Free Gloves

K202377 · LYY

Hi-Care Thai Gloves Co. , Ltd.

General Hospital · 103d

Cleared Dec 01, 2020

Apolo D / Apolo S

K202388 · KPR

Vmi Tecnologias Ltda

Radiology · 102d

Cleared Dec 01, 2020

Stryker Arthroscope

K202659 · HRX

Stryker

Orthopedic · 78d

Cleared Dec 01, 2020

Confirm Rx Insertable Cardiac Monitor

K202876 · MXC

Abbott (St. Jude Medical)

Cardiovascular · 64d

Cleared Dec 01, 2020

RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP...

K203199 · NVE

STERIS Corporation

General Hospital · 33d

Cleared Nov 30, 2020

Bright High Flow

K200155 · EBF

Genoss Co., Ltd.

Dental · 313d

Cleared Nov 30, 2020

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical...

K200372 · GEI

Modern Medical Equipment...

General & Plastic Surgery · 290d

Cleared Nov 30, 2020

Avenda Health Treatment System

K201687 · GEX

Avenda Health, Inc.

General & Plastic Surgery · 161d