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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Digital Radiographic System
Imaging Dynamics Company Ltd
1800 X4C
In Commercial Distribution

  • 00823073061019 ()

  • Height: 244 Centimeter
  • Stand and Detector Head
  • Weight: 875 Kilogram


  • Stationary basic diagnostic x-ray system, digital
Digital Medical X-ray Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
uDR 596i
In Commercial Distribution

  • 06971576833023 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
NANO-X IMAGING LTD
2.2.
In Commercial Distribution

  • 07290018465004 ()


  • Multi-directional tomography x-ray system
The Alma Lasers Soprano Titanium Laser System consists of: •System console (contains the laser diodes, the system software, power supply, andvarious other electronic and mechanical parts) •Operator control panel with touch-screen technology (GUI) •Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously Premarket Notification Traditional 510(k) Section 8: Page 2 of 4 Alma Lasers Soprano Titanium • 810 nm applicator • 755 nm applicator • Small NIR applicator • Footswitch and other laser safety accessories
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121829 ()
AASP05091845BSR0001

  • Dermatological diode laser system
  • Intense pulsed light skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121812 ()
AASP30111208

  • Dermatological diode laser system
  • Intense pulsed light skin surface treatment system
The D-SPECT® system is a single photon emission computing tomography system (SPECT) intended for detection of radioisotope tracer uptake in the patient’s body and to produce cross-sectional images through computer reconstruction of the data.
SPECTRUM DYNAMICS MEDICAL, INC
002
In Commercial Distribution

  • 07290108670097 ()
8010517-01

  • SPECT system, annular detector array
No Description
BREG, INC.
EXTENSION PANEL, EPIC LP BELT
In Commercial Distribution

  • 00672736140963 ()
SP30010-000

  • Lumbar spine orthosis
No Description
LivaNova Deutschland GmbH
S5 Min.I. Control Panel MRP85
In Commercial Distribution

  • 04033817902775 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
S5 Min.I. Control Panel MRP150
In Commercial Distribution

  • 04033817902768 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Control Panel for 2 MRP85
In Commercial Distribution

  • 04033817902744 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Control Panel for 1 MRP
In Commercial Distribution

  • 04033817902720 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Control Panel for 2 MRP85
In Commercial Distribution

  • 04033817900825 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Control Panel for 1 MRP
In Commercial Distribution

  • 04033817900818 ()


  • Cardiopulmonary bypass system, roller type
Healgen (DrugConfirm) - NO THC + PCP - 5 Panel Clicker Cup Test: AMP1000/COC300/mAMP1000/MOP2000/PCP25
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-253
In Commercial Distribution

  • 00856464008584 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
5 Multi Drug Test Panel (AMP 1000 • COC 300 • MET 1000 • OPI 2000 • THC 50)
IDUN SOLUTIONS LLC
21115061010308-B
In Commercial Distribution

  • 00857275007438 ()
  • 00857275007537 ()


  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
5 Multi Drug Test Panel (BZO 300 • COC 300 • MET 1000 • MOP 300 • THC 50)
IDUN SOLUTIONS LLC
21505040010308
In Commercial Distribution

  • 00857275007391 ()
  • 00857275007513 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Tech Subsidiary Acquisition
USSCup-5M
Not in Commercial Distribution

  • 00858998006036 ()
USSCup-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
NexScreen Drug Dip Card 9 Panel COC150/THC50/OPI2000/AMP500/MET500/ PCP25/BZO300/BAR300/MTD300
NEXSCREEN, LLC
NCard-12-BUP
In Commercial Distribution

  • 00858984006316 ()
NCard-12-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
NexScreen Drug Dip Card 9 Panel COC150/THC50/OPI2000/AMP500/MET500/ PCP25/BZO300/BAR300/MTD300
NEXSCREEN, LLC
NCard-09-01
In Commercial Distribution

  • 00858984006309 ()
NCard-09-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ALYON Series Spring Arm, Dual Flat Panel Monitor is used with the ALYON Suspension System
STERIS CORPORATION
ALYON Suspension System
In Commercial Distribution

  • 00724995222468 ()
LYS000005

  • Medical monitor/light mount
ALYON Series Spring Arm, Single Flat Panel Monitor is used with the ALYON Suspension System
STERIS CORPORATION
ALYON Suspension System
In Commercial Distribution

  • 00724995222437 ()
LYS000001

  • Medical monitor/light mount
MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution

  • 00860113002083 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup – AMP, BZO, BUP, COC, MET, MTD, MDMA, OPI, OXY, THC
DEUS VULT, LLC
P33-10-MET
Not in Commercial Distribution

  • 00860004081661 ()
  • 00860004081654 ()
  • 00860004081647 ()
P33-10-MET

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution

  • 00860003196991 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution

  • 00860003196953 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The A-Series Spindle Single Flat Panel Monitor is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution

  • 00724995190309 ()
LAS000007

  • Medical monitor/light mount
Five Panel PreScreen Plus Mini Cup (CLIA Waived) Drug Combo: COC|AMP|MAMP|THC|OPI
MERGERS MARKETING, INC.
PSC-DOA-254M
In Commercial Distribution

  • 20851000007162 ()
  • 10851000007165 ()
  • 00851000007168 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PS-DOA-254
In Commercial Distribution

  • 00850557007140 ()
  • 00850557007157 ()
  • 10850557007154 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel Clear Scan Drug Test Cup Drug Combo: BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
CSC-564
In Commercial Distribution

  • 00850557007881 ()
  • 00850557007898 ()
  • 10850557007895 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
PSC-DOA-564
In Commercial Distribution

  • 00850557007522 ()
  • 00850557007539 ()
  • 10850557007536 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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