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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13 Panel DOA Test clear Round Cup With Clicker; +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-2135A3
In Commercial Distribution

  • 20816490020923 ()
  • 10816490020926 ()
  • 00816490020929 ()
HCDOAV-2135A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test clear Round Cup With Clicker +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-264A3
In Commercial Distribution

  • 20816490020916 ()
  • 10816490020919 ()
  • 00816490020912 ()
HCDOAV-264A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-274A3
In Commercial Distribution

  • 20816490020886 ()
  • 10816490020889 ()
  • 00816490020882 ()
HCDOAV-274A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Round Cup +3 Adulterant Test Strips OXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-254A3
In Commercial Distribution

  • 20816490020848 ()
  • 10816490020841 ()
  • 00816490020844 ()
HCDOAV-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-7104A3
In Commercial Distribution

  • 20816490020770 ()
  • 10816490020773 ()
  • 00816490020776 ()
HCDOAV-7104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-3104A3
In Commercial Distribution

  • 20816490020749 ()
  • 10816490020742 ()
  • 00816490020745 ()
HCDOAV-3104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-4104A3
In Commercial Distribution

  • 20816490020732 ()
  • 10816490020735 ()
  • 00816490020738 ()
HCDOAV-4104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000144
In Commercial Distribution

  • 00847661005759 ()
12000144

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
Buffer based solution with containing non-pathogenic bacterial strains with the T2Biothreat Panel target sequences.
T2 BIOSYSTEMS, INC.
85-11396
In Commercial Distribution

  • M70883113950 ()
  • M70885113963 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel.
T2 BIOSYSTEMS, INC.
80-08072
In Commercial Distribution

  • M70880080720 ()
  • M70880080723 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, reagent
The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria panel.
T2 BIOSYSTEMS, INC.
80-07342
In Commercial Distribution

  • M70880073423 ()
  • M70880050580 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, reagent
The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
80-01689
In Commercial Distribution

  • M70880016893 ()
  • M70880009660 ()


  • Multiple Candida species nucleic acid IVD, reagent
QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC042
Not in Commercial Distribution

  • 20812125010062 ()
AC042

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 10810038636990 ()
  • 00810038636993 ()
  • 30855944007278 ()
ACDOA-754-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (6 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00810038632988 ()
  • 30810038632989 ()
ACDOA-754-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CVi Injector p/n 800620-024 Contents: CVi Injector Head (Siemens), Control Panel, & Power Supply
ACIST MEDICAL SYSTEMS, INC.
014658
In Commercial Distribution

  • 40841716101883 ()


  • Angiography contrast medium injection system, line-powered, mobile
U-Screen Squared Integrated Cup with 4 Panel Drug Screen for (COC/OPI2000/AMP/MET).
Instant Technologies, Inc.
USSCup-4NT
In Commercial Distribution

USSCup-4NT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Natura+ Urostomy Small Pouch With Soft Tap, Transparent 1-Sided Comfort Panel, 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
421074
Not in Commercial Distribution

  • 10768455133342 ()
  • 00768455133345 ()
  • 00768455189700 ()


  • Multiple-piece urostomy bag, open-ended
Natura+ Urostomy Pouch With Soft Tap, Transparent With 1-Sided Comfort Panel, 2 3/4"
CONVATEC, PURCHASING DEPARTMENT
413439
In Commercial Distribution

  • 10768455128898 ()
  • 00768455128891 ()
  • 00768455187652 ()


  • Multiple-piece urostomy bag, open-ended
Natura+ Urostomy Pouch With Soft Tap, Transparent With 1-Sided Comfort Panel, 2 1/4"
CONVATEC, PURCHASING DEPARTMENT
413438
In Commercial Distribution

  • 10768455128874 ()
  • 00768455128877 ()
  • 00768455187645 ()


  • Multiple-piece urostomy bag, open-ended
Natura+ Urostomy Pouch With Soft Tap, Transparent With 1-Sided Comfort Panel, 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
413437
In Commercial Distribution

  • 10768455128850 ()
  • 00768455128853 ()
  • 00768455187638 ()


  • Multiple-piece urostomy bag, open-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Large
CONVATEC, PURCHASING DEPARTMENT
416783
In Commercial Distribution

  • 10768455114693 ()
  • 00768455114696 ()
  • 00768455188703 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Large
CONVATEC, PURCHASING DEPARTMENT
416782
In Commercial Distribution

  • 10768455114686 ()
  • 00768455114689 ()
  • 00768455188697 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Mini Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Medium
CONVATEC, PURCHASING DEPARTMENT
416781
In Commercial Distribution

  • 10768455114679 ()
  • 00768455114672 ()
  • 00768455188680 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Medium
CONVATEC, PURCHASING DEPARTMENT
416778
In Commercial Distribution

  • 10768455114648 ()
  • 00768455114641 ()
  • 00768455188659 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Mini Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Small
CONVATEC, PURCHASING DEPARTMENT
416777
In Commercial Distribution

  • 10768455114631 ()
  • 00768455114634 ()
  • 00768455188642 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Mini Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Small
CONVATEC, PURCHASING DEPARTMENT
416776
In Commercial Distribution

  • 10768455114624 ()
  • 00768455114627 ()
  • 00768455188635 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Small
CONVATEC, PURCHASING DEPARTMENT
416775
In Commercial Distribution

  • 10768455114617 ()
  • 00768455114610 ()
  • 00768455188628 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Small
CONVATEC, PURCHASING DEPARTMENT
416774
In Commercial Distribution

  • 10768455114600 ()
  • 00768455114603 ()
  • 00768455188611 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy, 14 in., Drainable Pouch with 1 Sided Comfort Panel, Transparent, Straight, Extra-Large
CONVATEC, PURCHASING DEPARTMENT
405406
Not in Commercial Distribution

  • 10768455104779 ()
  • 00768455104772 ()
  • 80768455104778 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 2 1/4 in
CONVATEC, PURCHASING DEPARTMENT
401532
Not in Commercial Distribution

  • 10768455103499 ()
  • 00768455103492 ()
  • 80768455103498 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 3/4 in
CONVATEC, PURCHASING DEPARTMENT
401531
Not in Commercial Distribution

  • 10768455103482 ()
  • 00768455103485 ()
  • 80768455103481 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 1/2 in
CONVATEC, PURCHASING DEPARTMENT
401530
Not in Commercial Distribution

  • 10768455103475 ()
  • 00768455103478 ()
  • 80768455103474 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 1/4 in
CONVATEC, PURCHASING DEPARTMENT
401529
Not in Commercial Distribution

  • 10768455103468 ()
  • 00768455103461 ()
  • 80768455103467 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 2 3/4 in
CONVATEC, PURCHASING DEPARTMENT
401524
Not in Commercial Distribution

  • 10768455103413 ()
  • 00768455103416 ()
  • 80768455103412 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 2 1/4 in
CONVATEC, PURCHASING DEPARTMENT
401523
Not in Commercial Distribution

  • 10768455103406 ()
  • 00768455103409 ()
  • 80768455103405 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 1 3/4 in
CONVATEC, PURCHASING DEPARTMENT
401522
Not in Commercial Distribution

  • 10768455103390 ()
  • 00768455103393 ()
  • 80768455103399 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 1 1/2 in
CONVATEC, PURCHASING DEPARTMENT
401521
Not in Commercial Distribution

  • 10768455103383 ()
  • 00768455103386 ()
  • 80768455103382 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 2 3/4"
CONVATEC, PURCHASING DEPARTMENT
401514
In Commercial Distribution

  • 10768455103369 ()
  • 00768455103362 ()
  • 00768455182534 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 2 1/4"
CONVATEC, PURCHASING DEPARTMENT
401513
In Commercial Distribution

  • 10768455103352 ()
  • 00768455103355 ()
  • 00768455182527 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
401512
In Commercial Distribution

  • 10768455103345 ()
  • 00768455103348 ()
  • 00768455182510 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 1 1/2"
CONVATEC, PURCHASING DEPARTMENT
401511
In Commercial Distribution

  • 10768455103338 ()
  • 00768455103331 ()
  • 00768455182503 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
401510
In Commercial Distribution

  • 10768455103321 ()
  • 00768455103324 ()
  • 00768455182497 ()


  • Multiple-piece urostomy bag, open-ended
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
Human lymphocytes for 12 detections of human HLA-DR/DQ antibodies in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823350
Not in Commercial Distribution

  • 07611969965717 ()


  • HLA class II antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)
Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependend microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823300
Not in Commercial Distribution

  • 07611969965700 ()


  • HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)
Human lymphocytes for 12 detections of human HLA-DR/DQ antibodies in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823350
Not in Commercial Distribution

  • 07611969952946 ()
823350

  • HLA class II antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)
Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823300
Not in Commercial Distribution

  • 07611969952939 ()
823300

  • HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)
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