Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Quark C12x is a System for ECG and Stress Electrocardiography testing. ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients.
C O S M E D SRL
Quark C12x
In Commercial Distribution

  • 18052400180263 ()


  • Cardiac stress exercise monitoring system
InspiredBath Transfer Product Description: Ultima Access Assembly Kit, S/M
Drive Devilbiss Healthcare
CH-5130
Not in Commercial Distribution

  • 00822383975016 ()


  • Patient lifting system bath chair
Salmonella OMC Group: I, J, K, M, N, O, P
PRO-LAB, INCORPORATED
PLA006
In Commercial Distribution

  • 00817978020035 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
POWER PROSTHETIC KIT 1.2mm: Ankylos,Neobiotech, Dio, Hiossen/Ostem, Megagen.1.25mm: Astra, Dentium, Zimmer.1.3mm: Japan .etc.B/M: Branemark. Nobel Biocare.S/M: Straumann.
Power Dental U.S.A. Inc.
N7813N
In Commercial Distribution

  • D943N7813N00 ()
N7813N

  • Intraoperative orthopaedic bone pin/screw, single-use
No Description
BIOMET SPINE LLC
14-589703L
In Commercial Distribution

  • 00880304926042 ()

  • 4.75 TI LEFT OFFSET CONN, M LEFT OFFSET CONNECTOR
14-589703L

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
14-589703R
In Commercial Distribution

  • 00880304926035 ()

  • 4.75 TI RIGHT OFFSET CONN, M RIGHT OFFSET CONNECTOR
14-589703R

  • Bone-screw internal spinal fixation system, non-sterile
Stat Profile pHOx Plus/L/C/M W/R Tubing Set
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/L/C/M
In Commercial Distribution

  • 00385480329651 ()
32965

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
STAT PROFILE/M/ULTRA CAPILLARY TUBE KIT: 250uL WITH Li HEPARIN
NOVA BIOMEDICAL CORPORATION
ULTRA
In Commercial Distribution

  • 00385480115339 ()
  • 00385489115330 ()
11533

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
HOSE ASSEMBLY 3‘ DISS F X DISS M CHECK AIR MRI
OHIO MEDICAL, LLC
HS-03UA-DFDCC4M
In Commercial Distribution

  • 00628101517748 ()
HS-03UA-DFDCC4M

  • General-gas low pressure tubing, reusable
HOSE ASSEMBLY 3‘ DISS F X DISS M CHECK N2O MRI
OHIO MEDICAL, LLC
HS-03U2-DFDCC4M
In Commercial Distribution

  • 00628101517106 ()
HS-03U2-DFDCC4M

  • General-gas low pressure tubing, reusable
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