Search FDA 510(k) Database

Cleared Jan 27, 2023

F&P Airvo 3

K221338 · QAV

Fisher & Paykel Healthcare

Anesthesiology · 263d

Cleared Jan 27, 2023

FUJIFILM Endoscope Model EI-740D/S

K221551 · FDS

Fujifilm Corporaton

Gastroenterology & Urology · 241d

Cleared Jan 27, 2023

QOCA image Smart CXR Image Processing System

K221868 · QFM

Quanta Computer, Inc.

Radiology · 214d

Cleared Jan 27, 2023

Sim&Size

K222664 · PZO

Sim&Cure

Neurology · 147d

Cleared Jan 27, 2023

Prophecy Preoperative Navigation Alignment System

K222835 · HSN

Wrightmedicaltechnologyinc

Orthopedic · 129d

Cleared Jan 27, 2023

EVA15 insufflator

K222901 · HIF

Palliare , Ltd.

Obstetrics & Gynecology · 126d

Cleared Jan 27, 2023

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

K223016 · PSZ

Bd

Microbiology · 120d

Cleared Jan 27, 2023

GEM Premier ChemSTAT

K223090 · CGA

Instrumentation Laboratory CO

Chemistry · 119d

Cleared Jan 27, 2023

C2 Xplore

K223254 · ETN

Inomed Medizintechnik GmbH

Ear, Nose, Throat · 98d

Cleared Jan 27, 2023

14HQ721G-B

K223546 · MQB

Lg Electronics.Inc

Radiology · 63d

Cleared Jan 27, 2023

Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use...

K223903 · LZA

Semperit Investments Asia Pte , Ltd.

General Hospital · 30d

Cleared Jan 27, 2023

360CAS

K223927 · OLO

Kico Knee Innovation Company Pty Limited

Orthopedic · 28d

Cleared Jan 26, 2023

RMF-2000

K220073 · MUE

DRTECH Corporation

Radiology · 381d

Cleared Jan 26, 2023

Sterile Surgical Powder Free Latex Glove

K221424 · KGO

New Era Medicare Sdn. Bhd.

General Hospital · 255d

Cleared Jan 26, 2023

ECHELON Oval V6.2 MRI System

K221619 · LNH

Fujifilm Healthcare Corporation

Radiology · 237d

Cleared Jan 26, 2023

Ortho Device, ADAPTIX 3D Orthopedic Imaging System

K221949 · IZF

Pausch Medical GmbH

Radiology · 205d

Cleared Jan 26, 2023

Global Modular Replacement System, Modular Replacement System, Modular...

K222056 · JDI

Howmedica Osteonics Corp., Dba...

Orthopedic · 198d

Cleared Jan 26, 2023

Surgical Gown

K222403 · FYA

Guangzhou Fuzelong Hygiene Material...

General Hospital · 170d

Cleared Jan 26, 2023

Aristotle Colossus Guidewire

K222437 · MOF

Scientia Vascular, Inc.

Neurology · 167d

Cleared Jan 26, 2023

Flexible Suturing System with Anchors (FSSA)

K222589 · MBI

Integrity Orthopaedics, Inc.

Orthopedic · 153d

Cleared Jan 26, 2023

Revogene

K222779 · OOI

Meridian Bioscience, Inc.

Microbiology · 134d

Cleared Jan 26, 2023

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for...

K223415 · LZA

Mah Sing Healthcare Sdn. Bhd.

General Hospital · 77d

Cleared Jan 26, 2023

PALLAS Premium

K223588 · GEX

Laseroptek Co., Ltd.

General & Plastic Surgery · 56d

Cleared Jan 25, 2023

PowerPAK Syringe

K220114 · MEG

Vault Paragon Group, Inc.

General Hospital · 376d