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PCLOK II

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·PCL Inc.·1 device

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WCD 3000

RNET SYSTEM, IV RECEIVING TERMINAL, TRANSMITTER

FDA 510(k)

STRESS HANDLER

FDA 510(k)
FDA Class 1 ·Physical Medicine

Specimen Immobilizer

FDA UDI
Perimeter Medical Imaging AI, Inc.·00754016215025·The OTIS 2.1 system includes a single-use speci...

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Orchestra/Orchestra Plus C3PR/C3PRH, Orchestra Plus Link, USB adapter for CPR3H, Smart ECG

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs

FDA 510(k)
FDA Class 1 ·General Hospital

DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

FDA 510(k)
FDA Class 1 ·General Hospital

PFM PROFESSIONAL 7000 SPIROMETER

FDA 510(k)
FDA Class 2 ·Anesthesiology

BIOLAND BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)

FDA 510(k)
FDA Class 1 ·General Hospital

PUL-TRON 100K PROFESSIONAL SPIROMETER

FDA 510(k)
FDA Class 2 ·Anesthesiology

SOMNOtouch RESP accessory

FDA UDI
SOMNOmedics GmbH·04250413404087·

SOMNOtouch RESP accessory

FDA UDI
SOMNOmedics GmbH·04250413405022·