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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No Description
PROTECT U GUARD, LLC
P10041
In Commercial Distribution

  • B086100411 ()
  • B086100410 ()


  • Surgical/medical face mask, single-use
No Description
PROTECT U GUARD, LLC
P10033
In Commercial Distribution

  • B086100331 ()
  • B086100330 ()


  • Surgical/medical face mask, single-use
No Description
PROTECT U GUARD, LLC
P10032
In Commercial Distribution

  • B086100321 ()
  • B086100320 ()


  • Surgical/medical face mask, single-use
No Description
PROTECT U GUARD, LLC
P10031
In Commercial Distribution

  • B086100311 ()
  • B086100310 ()


  • Surgical/medical face mask, single-use
Protect U Guard Flexible Fabric Adhesive Bandages Round 2.5cm
PROTECT U GUARD, LLC
P19142
In Commercial Distribution

  • B086291422 ()
  • B086191421 ()
  • B086091420 ()

  • Circumference: 25 Millimeter


  • Adhesive bandage
HD Rapid Simplified / 07 150grhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Vertex-Dental B.V.
HDARSP0700150
Not in Commercial Distribution

  • 08719425505121 ()


  • Dental appliance fabrication material, resin
Hoen Nerve Hook Straight 22cmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
KOROS U.S.A., INC.
7225-05
In Commercial Distribution

  • 00840199507528 ()
  • 10840199507525 ()

  • 9x12mm
7225-05

  • Soft-tissue surgical hook, reusable
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Black
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000813 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - White
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000806 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Navy
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000790 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Red
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000783 ()


  • Room humidifier
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution

  • 08052990321759 ()


  • Expiratory peak flow meter, digital
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
mSpirometer
In Commercial Distribution

  • 08052990321636 ()


  • Expiratory peak flow meter, digital
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution

  • 08052990321124 ()
911105

  • Expiratory peak flow meter, digital
DRSHD 1080p System, Rev 7https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Nds Surgical Imaging LLC
DRSHD.7
Not in Commercial Distribution

  • 00817613020000 ()


  • Endoscopic video image processing unit
GAS-ASSISTED SPRAY SET ENDOSCOPIC APP. 5MM 30 CM, 1:1 RATIO
Micromedics, Inc.
SA-3654
In Commercial Distribution

  • 10815634020075 ()
  • 00815634020078 ()
  • 20815634020072 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
6mm Kerrison Rongeur, 350mm https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Osseus Fusion Systems, LLC
1760-7070
In Commercial Distribution

  • B06217607070 ()
1760-7070

  • Spinal rongeur
Gastric Bypass Pack _Sterile_3EA/CShttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
GRI Medical & Electronic Technology Co., Ltd.
LGH011
In Commercial Distribution

  • 26931918174539 ()
  • 16931918174532 ()


  • General surgical procedure kit, non-medicated, single-use
No Description
W.H. Holden, Inc.
10-5530
In Commercial Distribution

  • D9281055300 ()


  • Dental cheek retractor, professional, reusable
No Description
DIAGNOSTICA STAGO
00975
In Commercial Distribution

  • 03607450009750 ()
  • 13607450009757 ()


  • Buffered wash solution IVD
No Description
BIOTRONIK SE & Co. KG
492817
In Commercial Distribution

  • 04035479188399 ()
492817

  • Cardiac pulse generator programmer
Calibrator U - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995519
In Commercial Distribution

  • 00630414598468 ()
  • 00630414190907 ()
10995519

  • Myoglobin IVD, calibrator
No Description
Roche Diagnostics GmbH
06390579001
In Commercial Distribution

  • 04015630932276 ()
06390579001

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
No Description
Zimmer, Inc.
SSI005667
In Commercial Distribution

  • 00889024586956 ()
SSI005667

  • Surgical instrument handle, non-torque-limiting
No Description
Octostop Inc
CO-02
In Commercial Distribution

  • B525CO020 ()


  • Radiological whole-body positioner
No Description
Octostop Inc
CO-01
In Commercial Distribution

  • B525CO010 ()


  • Radiological whole-body positioner
No Description
ACCUTRON, INC.
46500-US
In Commercial Distribution

  • 00813830023190 ()
46500-US

  • Oxygen/air/nitrous oxide breathing gas mixer
No Description
ACCUTRON, INC.
36500-US
In Commercial Distribution

  • 00813830022643 ()
36500-US

  • Oxygen/air/nitrous oxide breathing gas mixer
Hyaluronidase 80 U/mL. 6x1.0 ml
Origio A/S
ART-4007-A
In Commercial Distribution

  • 20888937818899 ()
  • 00888937818918 ()


  • IVF medium
No Description
POLLOGEN LTD
STOP VX2 MODEL U
In Commercial Distribution

  • 07290016586626 ()
34690000BK-US

  • Multi-modality skin/body contouring system
No Description
POLLOGEN LTD
STOP U MODEL UXV
In Commercial Distribution

  • 07290016586442 ()
34650000BP-US

  • Multi-modality skin/body contouring system
Symmetry® Forceps, U.S Pattern Tube Occluding Forceps, 6 in
SYMMETRY SURGICAL INC.
17-7280
In Commercial Distribution

  • 00887482049372 ()

  • Length: 6 Inch
17-7280

  • Dressing/utility forceps, scissors-like, reusable
Symmetry® Forceps, U.S. Pattern Tube Occluding, (Heavy Jaw), 8 in
SYMMETRY SURGICAL INC.
17-7282
In Commercial Distribution

  • 00887482057070 ()

  • Length: 8 Inch
17-7282

  • Dressing/utility forceps, scissors-like, reusable
Symmetry® Forceps, U.S. Pattern Tube Occluding, 7 1/4 in
SYMMETRY SURGICAL INC.
17-7281
In Commercial Distribution

  • 00887482057063 ()

  • Length: 7.25 Inch
17-7281

  • Dressing/utility forceps, scissors-like, reusable
U OF UTAH VASCULAR TRAY
Cardinal Health 200, LLC
SCV56VT194
In Commercial Distribution

  • 50195594031488 ()
  • 10195594031480 ()
SCV56VT194

  • Cardiothoracic surgical procedure kit, medicated, single-use
U OF UTAH INTERVENTIONAL TRAY
Cardinal Health 200, LLC
SAN56PI114
In Commercial Distribution

  • 50195594067692 ()
  • 10195594067694 ()
SAN56PI114

  • General surgical procedure kit, non-medicated, single-use
U OF UTAH INTERVENTIONAL TRAY
Cardinal Health 200, LLC
SAN56PI113
In Commercial Distribution

  • 50195594004222 ()
  • 10195594004224 ()
SAN56PI113

  • General surgical procedure kit, non-medicated, single-use
U OF UTAH INTERVENTIONAL TRAY
Cardinal Health 200, LLC
SAN56PI117
In Commercial Distribution

  • 50195594386465 ()
  • 10195594386467 ()
SAN56PI117

  • General surgical procedure kit, non-medicated, single-use
MINOR W U BAR TRAY
Cardinal Health 200, LLC
SBA13MUCO1
In Commercial Distribution

  • 50195594080363 ()
  • 10195594080365 ()
SBA13MUCO1

  • General surgical procedure kit, medicated
Arte Replica Anterior DTS U
LM-Dental
451-452ESTU
In Commercial Distribution

  • 06438311707860 ()


  • Dental spatula, reusable
LM Build-up Trimmer DTS U
LM-Dental
130-131ESTU
In Commercial Distribution

  • 06438311707501 ()


  • Dental excavator, reusable
Arte Replica Posterior DTS U
LM-Dental
448-449ESTU
In Commercial Distribution

  • 06438311707273 ()


  • Dental spatula, reusable
Arte Eccesso DD DTS U
LM-Dental
307-308DDESTU
In Commercial Distribution

  • 06438311707242 ()


  • Dental spatula, reusable
Arte Condensa DD DTS U
LM-Dental
488-489DDESTU
In Commercial Distribution

  • 06438311707235 ()


  • Dental spatula, reusable
Arte Fissura DD DTS U
LM-Dental
481-487DDESTU
In Commercial Distribution

  • 06438311707228 ()


  • Dental spatula, reusable
Arte Modella DD DTS U
LM-Dental
442-443DDESTU
In Commercial Distribution

  • 06438311707211 ()


  • Dental spatula, reusable
Arte Applica DD DTS U
LM-Dental
46-49DDESTU
In Commercial Distribution

  • 06438311707204 ()


  • Dental spatula, reusable
Ligature Director DTS U, Orthodontics
LM-Dental
411-415ESTU
In Commercial Distribution

  • 06438311110592 ()


  • Orthodontic ligature director
Ligature Tucker DTS U, Orthodontics
LM-Dental
414-415ESTU
In Commercial Distribution

  • 06438311045337 ()


  • Orthodontic ligature director
Mini Spatula DTS U, Restoration
LM-Dental
444-445DDESTU
In Commercial Distribution

  • 06438311038155 ()


  • Manual dental burnisher, reusable
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