SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(8781 results)

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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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NA - 08806088511153

The GM60A-32S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM60A-32S
In Commercial Distribution

  • 08806088511153 ()


  • Mobile basic diagnostic x-ray system, digital

NA - 08806088351889

The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50A
In Commercial Distribution

  • 08806088351889 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088351872

The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50
In Commercial Distribution

  • 08806088351872 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088088266

The GM60A-40S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM60A-40S
In Commercial Distribution

  • 08806088088266 ()


  • Mobile basic diagnostic x-ray system, digital

NA - 08806086403467

The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC80
In Commercial Distribution

  • 08806086403467 ()


  • Stationary basic diagnostic x-ray system, digital

Optima - 00840682145749

No Description
GE MEDICAL SYSTEMS, INC.
XR240amx HD Upgrade Gen2
In Commercial Distribution

  • 00840682145749 ()


  • Mobile basic diagnostic x-ray system, digital

Optima - 00840682142175

Optima XR646 HD System
GE Hualun Medical Systems Co., Ltd
XR646 HD
In Commercial Distribution

  • 00840682142175 ()


  • Stationary basic diagnostic x-ray system, digital

Optima - 00840682142168

XR646HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR646 HD Upgrade
In Commercial Distribution

  • 00840682142168 ()


  • Stationary basic diagnostic x-ray system, digital

ArtPiX Mobile EZ2GO - 03701440100172

No Description
THALES AVS FRANCE SAS
62833765
In Commercial Distribution

  • 03701440100172 ()


  • Stationary basic diagnostic x-ray system, digital

TruSight™ Oncology Comprehensive - 00816270020217

The TruSight Oncology Comprehensive assay is an enrichment-based targeted next generation sequencing (NGS) in-vitro diagnostic test comprised of library preparation and enrichment reagents to enable DNA and/or RNA sequencing from Formalin-Fixed, Paraffin-Embedded (FFPE) tissue from solid tumors encompassing multiple cancer types.
ILLUMINA, INC.
20032573
In Commercial Distribution

  • 00816270020217 ()


  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

2020 Imaging Podiatry System HF - 00817100020148

X-Ray System, Podiatry DR Ready (70kVp,10mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR410i
In Commercial Distribution

  • 00817100020148 ()
PXS-710

  • Stationary basic diagnostic x-ray system, digital

Nanox.ARC - 07290018465004

No Description
NANO-X IMAGING LTD
2.2.
In Commercial Distribution

  • 07290018465004 ()


  • Multi-directional tomography x-ray system

OMNERA 400T - 07350008750050

Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0180
In Commercial Distribution

  • 07350008750050 ()


  • Stationary basic diagnostic x-ray system, digital

OMNERA 400A - 07350008750012

Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0072
In Commercial Distribution

  • 07350008750012 ()


  • Stationary basic diagnostic x-ray system, digital

uDR - 00810030350002

The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
UIH TECHNOLOGIES LLC
uDr 596i
In Commercial Distribution

  • 00810030350002 ()


  • Stationary basic diagnostic x-ray system, analogue

uDR - 06971576833023

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

Xplorer 1800 Digital Radiographic System - 00823073061019

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

Soprano Titanium System 230V - 17290110121829

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

Diode 3D Trio 4cm HP for Soprano Titanium - 17290110121812

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121812 ()
AASP30111208

  • Dermatological diode laser system
  • Intense pulsed light skin surface treatment system

HarmonyAIR - 00724995190309

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

HarmonyAIR - 00724995171759

The Single Flat Panel Monitor Yoke Assembly is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171759 ()
10100167

  • Medical monitor/light mount

P33 - 00860004081654

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

MD DrugScreen - 00860003196991

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

MD DrugScreen - 00860003196953

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

Six Panel Clear Scan Drug Test Cup - 00850557007881

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) - 00850557007522

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

Six Panel PreScreen Plus Cup (CLIA Waived) - 00850557007461

Six Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PSC-DOA-264
In Commercial Distribution

  • 00850557007461 ()
  • 00850557007478 ()
  • 10850557007475 ()


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

Five Panel PreScreen Plus Dip Card (CLIA Waived) - 00850557007386

Five Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-854
In Commercial Distribution

  • 00850557007386 ()
  • 00850557007393 ()
  • 10850557007390 ()


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

Five Panel PreScreen Plus Dip Card (CLIA Waived) - 00850557007362

Five Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BZO | COC | OPI | THC
MERGERS MARKETING, INC.
PS-DOA-754
In Commercial Distribution

  • 00850557007362 ()
  • 00850557007379 ()
  • 10850557007376 ()


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

Five Panel PreScreen Plus Dip Card (CLIA Waived) - 00850557007324

Five Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: BZO | COC | MET | MOR | THC
MERGERS MARKETING, INC.
PS-DOA-654
In Commercial Distribution

  • 00850557007324 ()
  • 00850557007331 ()
  • 10850557007338 ()


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

Five Panel Pre Screen Plus Dip Card (CLIA Waived) - 00850557007140

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

Five Panel PreScreen Plus Mini Cup (CLIA Waived) - 00851000007168

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

Healgen (Private Label) - 253 - 00856464008584

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

U-Screen - 00858998006036

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 - 00858984006309

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

PreKnow - 00857275007537

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

PreKnow - 00857275007513

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

NexScreen Drug Dip Card - 00858984006316

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

MD DrugScreen - 00860113002083

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

ALYON - 00724995222468

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
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