Search FDA 510(k) Database

Cleared Sep 21, 2018

BB-613 Watch Oximeter

K181006 · DQA

Bio-Beat Technologies , Ltd.

Anesthesiology · 158d

Cleared Sep 21, 2018

Pocket Colposcope System

K181034 · HEX

Hadleigh Health Technologies, LLC

Obstetrics & Gynecology · 156d

Cleared Sep 21, 2018

AEROmini Tracheobronchial Stent System

K181200 · JCT

Merit Medical Systems, Inc.

Anesthesiology · 137d

Cleared Sep 21, 2018

PSM 3-Way Silicone Foley Catheter

K181616 · EZL

Pathway, LLC

Gastroenterology & Urology · 94d

Cleared Sep 21, 2018

BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN

K181665 · LON

Becton, Dickinson and Company

Microbiology · 88d

Cleared Sep 21, 2018

Tranquil-L Interbody System

K181702 · MAX

Nexus Spine, LLC

Orthopedic · 86d

Cleared Sep 21, 2018

Arthrex FiberTak Suture Anchor

K181769 · MBI

Arthrex, Inc.

Orthopedic · 80d

Cleared Sep 21, 2018

VeriSuite

K181789 · LHN

Medcom GmbH

Radiology · 78d

Cleared Sep 21, 2018

InVivo Web Viewer

K181926 · LLZ

Anatomage, Inc.

Radiology · 65d

Cleared Sep 21, 2018

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)

K182043 · LYZ

Hebei Titans Hongsen Medical...

General Hospital · 53d

Cleared Sep 21, 2018

AquaShield System CO2

K182258 · FEQ

United States Endoscopy Group, Inc.

Gastroenterology & Urology · 31d

Cleared Sep 21, 2018

Volpara Imaging Software

K182310 · LLZ

Volpara Health Technologies Limited

Radiology · 28d

Cleared Sep 21, 2018

Spineology Navigation Instruments

K182345 · OLO

Spineology, Inc.

Orthopedic · 24d

Cleared Sep 20, 2018

MicroPort Orthopedics Total Hip Systems MR Labeling

K173898 · LZO

Microport Orthopedics Inc. (Mpo)

Orthopedic · 272d

Cleared Sep 20, 2018

EndoTool SubQ

K180366 · NDC

Al Pacheco and Associates

General Hospital · 220d

Cleared Sep 20, 2018

Katalyst Mark 1 Muscle Stimulation System Model 2

K181199 · NGX

Katalyst, Inc.

Physical Medicine · 136d

Cleared Sep 20, 2018

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

K181205 · PBK

Centers For Disease Control and...

Microbiology · 136d

Cleared Sep 20, 2018

OralTox Oral fluid Drug Test

K181305 · DJC

Premier Biotech, Inc.

Toxicology · 126d

Cleared Sep 20, 2018

Aequalis Flex Revive Shoulder System

K181420 · KWS

Tornier, Inc.

Orthopedic · 112d

Cleared Sep 20, 2018

Medline Patient Cables and Lead Wires

K181726 · DSA

Medline Industries, Inc.

Cardiovascular · 83d

Cleared Sep 20, 2018

LOGIQ P9

K181783 · IYN

Ge Healthcare

Radiology · 79d

Cleared Sep 20, 2018

Chiral Surgical Pedicle Screw System

K181995 · NKB

Chiral Surgical

Orthopedic · 56d

Cleared Sep 20, 2018

NICO Myriad

K182340 · GEI

Nico Corporation

Obstetrics & Gynecology · 23d

Cleared Sep 19, 2018

CSM Submerged3-L Implant System

K173141 · DZE

Csm Implant

Dental · 355d