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

Show Filters

LITTAUER STITCH SCISSORS 4.5" STR
K.T.SURGICO
2023
In Commercial Distribution

  • MASTER0007 ()
  • KTS0880111 ()
  • TMS1539413 ()
KTS0880111

  • General-purpose surgical scissors, single-use
Iris scissors str. 4.5"
K.T.SURGICO
2023
In Commercial Distribution

  • TMS1536411 ()
  • KTS0834211 ()
KTS0834211

  • General-purpose surgical scissors, single-use
Irrigation & Aspiration
HURRICANE MEDICAL INC
2023
In Commercial Distribution

  • 00813465010169 ()
  • 10813465010166 ()

  • Length: 22 Millimeter
  • Needle Gauge: 23 Gauge
2023

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
BEAUTIFIL FLOW PLUS F03 INC
SHOFU DENTAL CORPORATION
2023
In Commercial Distribution

  • E23520230 ()
2023

  • Dental composite resin
BANDAGE WOVEN FINGERTIP
Prostat First Aid, LLC
2023
In Commercial Distribution

  • 00814889011206 ()


  • Adhesive bandage
SINUS LIFT 1
Power Dental U.S.A. Inc.
2023
In Commercial Distribution

  • D9432023 ()
2023

  • Dressing/utility forceps, scissors-like, reusable
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
GEN4 Direct Access
CURBELL MEDICAL PRODUCTS, INC.
4C380U-Z103008
In Commercial Distribution

  • 00840828108041 ()
2023

  • Pillow speaker
A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.
DENT ZAR, INC.
1
In Commercial Distribution

  • D836PSLFH9 ()
2023

  • Dental/surgical polymerization lamp
truSculpt iD RF Device (Rebranded as truSculpt RF Device in June 2023)
CUTERA, INC.
truSculpt iD
In Commercial Distribution

  • 00816722021427 ()


  • Radio-frequency skin contouring system
ANA Nucleolar Positive Control - 2 x 1 ml
IMMUNO CONCEPTS INC
2023 (2)
In Commercial Distribution

  • M7490202321 ()
2023 (2)

  • Multiple antinuclear antibody (ANA) screening IVD, control
No Description
DIO Corporation
PP 2023
In Commercial Distribution

  • 08800049202197 ()


  • Dental guided surgery reference pin
4.0mm Plastic Castable Abutment, Non-hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
2023/2905
Not in Commercial Distribution

  • 00847236003043 ()


  • Dental implant suprastructure, temporary, preformed, single-use
TLIF(B) Trial L36 x W9 x H9
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557206031 ()
TI.2023

  • Spinal implant trial
Tinto Oct-2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • L502BSB2023 ()
BSB 2023

  • Oct-2 IVD, antibody
Diffuser of ready-to-use liquid solutions
Amil Care Corp.
1L-2L-5L (hub)
In Commercial Distribution

  • G0602023T0 ()
2023.t

  • Airborne device-disinfectant diffuser
No Description
MedicalCommunications GmbH
2023 (Build 2088)
In Commercial Distribution

  • 04260648620084 ()


  • Radiology picture archiving and communication system workstation
No Description
MedicalCommunications GmbH
2023 (Build 2167)
In Commercial Distribution

  • 04260648620077 ()


  • Radiology picture archiving and communication system workstation
No Description
MedicalCommunications GmbH
2023 (Build 2167)
In Commercial Distribution

  • 04260648620053 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
No Description
MedicalCommunications GmbH
2023 (Build 2088)
In Commercial Distribution

  • 04260648620039 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
No Description
EYEVAN INC.
748 50 2023
In Commercial Distribution

  • 04571445051514 ()


  • Spectacle frame
No Description
EYEVAN INC.
554 47 2023
In Commercial Distribution

  • 04571445049689 ()


  • Spectacle frame
No Description
EYEVAN INC.
414 46 2023
In Commercial Distribution

  • 04571445048651 ()


  • Spectacle frame
No Description
EYEVAN INC.
#414 46 2023
In Commercial Distribution

  • 04571445035347 ()


  • Spectacle frame
SINGLE SUNGLASS
Evolutioneyes, Inc.
NM SUN 2023
In Commercial Distribution

  • 00802807353927 ()


  • Tinted non-prescription spectacles
SINGLE SUNGLASS
Evolutioneyes, Inc.
ME SUN 2023
In Commercial Distribution

  • 00802807353910 ()


  • Tinted non-prescription spectacles
SINGLE SUNGLASS
Evolutioneyes, Inc.
MS SUN 2023
In Commercial Distribution

  • 00802807353903 ()


  • Tinted non-prescription spectacles
SINGLE READER
Evolutioneyes, Inc.
4221 2023 DEMI MERLOT
In Commercial Distribution

  • 00802807355129 ()


  • Magnifying spectacles
Radiography 7000 M digital mobile is a new motorized mobile x-ray system that includes: 1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023) 2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories 3. Eleva WorkSpot In addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed - Grid Landsc. SkyPlateE Large - Grid Landscape SkyPlate Large - Grid Portr. SkyPlate E Large - Grid Portrait SkyPlate Large - Grid Portrait SkyPlate Small - Handle for Skyplate Large - Portable Panel Protector - Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large) - Set of 50 WPD Hygienic Bags (small)
Philips Medical Systems DMC GmbH
712010
In Commercial Distribution

  • 00884838115521 ()


  • Mobile basic diagnostic x-ray system, digital
WESTCOTT Ophthalmic Tendons Scissors sh/sh.
Dimeda Instrumente GmbH
09.102.11
Not in Commercial Distribution

  • 04042796016595 ()

  • Length: 11 Centimeter


  • Intraocular scissors, conventional-hinge, reusable
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-1H2-12X20
Not in Commercial Distribution

  • 00081215031744 ()


  • Liposuction system cannula, single-use
< 1 2 3 4 5 ... 64 >