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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Linear Array Transducer
Shantou Institute of Ultrasonic Instruments Co., Ltd.
L14LC
In Commercial Distribution

  • 06938396400347 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
The NovaSure®Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
NovaSure Controller
In Commercial Distribution

  • 15420045500860 ()
RFC2010-115

  • Radio-frequency endometrial-ablation system generator
Exerciser to increase flexion and the extension range of motion of the joints of the second to the fifth fingers of the hand
LANTZ MEDICAL, INC.
Vector 1
In Commercial Distribution

  • B770VEC0 ()
Vector 1

  • Hand/wrist continuous passive motion exerciser
Almost Naked Hint of Mint is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
1.69oz
In Commercial Distribution

  • 00850014621940 ()
  • 10850014621947 ()
700350

  • Sexual lubricant
No Description
W.H. Holden, Inc.
10-7147
In Commercial Distribution

  • D9281071470 ()
  • D9281071471 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-5530EH
In Commercial Distribution

  • D928105530EH0 ()


  • Dental cheek retractor, professional, reusable
No Description
W.H. Holden, Inc.
10-5530-1
In Commercial Distribution

  • D92810553010 ()


  • Dental cheek retractor, professional, reusable
POC Growth Supplement is a media additive that greatly improves cell growth and morphology in primary cells found in post-mortem foetuses and products of conception (POC) in culture by exposing these cells to growth factors and cofactors that are known growth promoters.
GENIAL HELIX LTD
GGS - JL013
In Commercial Distribution

  • 05060174130151 ()
GGS - JL013

  • Assay development analyte-specific reagent IVD
No Description
W.H. Holden, Inc.
10-4021
In Commercial Distribution

  • D9281040210 ()


  • Dental elevator, tooth/root
Transcutaneous Electrical Stimulation Electrode
INNOVATIVE NEUROTRONICS, INC.
20-0500
In Commercial Distribution

  • 00858184006079 ()
  • 858184006086 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
IRIDEX CORPORATION
11256
In Commercial Distribution

  • 00851089000227 ()


  • Ophthalmic laser system beam guide
(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.
Wolfe & Associates Inc
RC10TCA
Not in Commercial Distribution

  • 00868401000261 ()
RC10TCA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(BZO/BAR)+(COC/THC)+(MET/OPI)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD with Cr, Ni, pH, Bl, S.G.
Wolfe & Associates Inc
RC12TCA
Not in Commercial Distribution

  • 00868401000254 ()
RC12TCA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Lafayette Range of Motion Inclinometer is a wireless digital goniometer/inclinometer that is capable of taking measurements in three different planes. It can record maximal range of motion movements in flexion/extension, rotation, or front to back. An easy-to-read LCD screen displays the real-time angle along with up to six previously recorded measurements. Capable of wireless communication with a second unit for dual inclinometer joint measurements.
LAFAYETTE INSTRUMENT COMPANY, INC.
ACU100
In Commercial Distribution

  • 00855170007409 ()
ACU100

  • Electronic goniometer/kinesiology sensor
No Description
KATENA PRODUCTS, INC.
K20-5005
In Commercial Distribution

  • 10841668112189 ()
  • 00841668112182 ()
K20-5005

  • Ophthalmic sponge
No Description
KATENA PRODUCTS, INC.
K20-5000
In Commercial Distribution

  • 10841668112172 ()
  • 00841668112175 ()
K20-5000

  • Ophthalmic sponge
No Description
Ortho8 Inc
08-0043
In Commercial Distribution

  • 00194832000366 ()


  • Intermittent venous compression system
STETHOSCOPE, SINGLE HEAD, UNC 1/EA, 50/BX, 100/CS
Asp Global, LLC
STAUNC
In Commercial Distribution

  • 00840216105928 ()


  • Mechanical external stethoscope
No Description
BIOTECHNOLOGY INSTITUTE SL
HTDS
In Commercial Distribution

  • 08435389802624 ()


  • Dental implant suprastructure, temporary, preformed, single-use
No Description
BIOTECHNOLOGY INSTITUTE SL
HTDP
In Commercial Distribution

  • 08435389802617 ()


  • Dental implant suprastructure, temporary, preformed, single-use
10 panel test cup, (BZO/BAR)+(OXY/MDMA)+(PCP/AMP)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-10M5
Not in Commercial Distribution

  • 00816565020359 ()
IMCA-10M5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests (for Impact Employees)
AMEDITECH INC.
IMCA-9CM5-5
Not in Commercial Distribution

  • 00816565020342 ()
IMCA-9CM5-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9CM5
Not in Commercial Distribution

  • 00816565020335 ()
IMCA-9CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (COC/THC)+(OXY/MDMA)+AMP+BZO+MET1000+MTD+OPI2000 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9A
Not in Commercial Distribution

  • 00816565020328 ()
IMCA-9A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 panel test cup, (BZO/BAR)+(COC/THC)+(MET/OPI)+(PCP/AMP)+MTD+OXY+PPX with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-11OP
Not in Commercial Distribution

  • 00816565020311 ()
IMCA-11OP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP1000)+BUP with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-13M
Not in Commercial Distribution

  • 00816565020304 ()
IMCA-13M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-12BUP
Not in Commercial Distribution

  • 00816565020298 ()
IMCA-12BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel test cup, (OXY/MDMA)+(PCP/AMP1000)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8CM5
Not in Commercial Distribution

  • 00816565020281 ()
IMCA-8CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 panel test cup, AMP1000/COC150/MET500/OPI2000/PCP25/THC50 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-6C1M5P
Not in Commercial Distribution

  • 00816565020274 ()
IMCA-6C1M5P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 panel test cup, (COC/THC)+AMP+BZ0+BUP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8BB
Not in Commercial Distribution

  • 00816565020267 ()
IMCA-8BB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 panel test cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-7P
Not in Commercial Distribution

  • 00816565020250 ()
IMCA-7P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 panel test cup, AMP/BAR/BZO/COC/MTD/OPI2000/OXY with Cr, Ni, pH, Bl, S.G. adulteration tests (CLIA Waived)
AMEDITECH INC.
IMCA-7MT-W
Not in Commercial Distribution

  • 00816565020243 ()
IMCA-7MT-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-5P
Not in Commercial Distribution

  • 00816565020236 ()
IMCA-5P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-5M
Not in Commercial Distribution

  • 00816565020229 ()
IMCA-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, BZO300/COC300/MTD300/OPI300/THC50 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-5BO3
Not in Commercial Distribution

  • 00816565020212 ()
IMCA-5BO3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/BZO/COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests (CLIA Waived)
AMEDITECH INC.
IMCA-5AB-W
Not in Commercial Distribution

  • 00816565020205 ()
IMCA-5AB-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 panel test cup, COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-3P
Not in Commercial Distribution

  • 00816565020199 ()
IMCA-3P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 panel test cup, COC/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-2P
Not in Commercial Distribution

  • 00816565020182 ()
IMCA-2P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 panel test cup, (COC/THC)+AMP+BZO+BUP+MET1000+MTD+OPI300
AMEDITECH INC.
IMC-8BB
Not in Commercial Distribution

  • 00816565020175 ()
IMC-8BB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 panel test cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC
AMEDITECH INC.
IMC-7P
Not in Commercial Distribution

  • 00816565020168 ()
IMC-7P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, BZO/COC/MET1000/OPI300/THC
AMEDITECH INC.
IMC-5MB300
Not in Commercial Distribution

  • 00816565020151 ()
IMC-5MB300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/MET1000/OPI2000/THC
AMEDITECH INC.
IMC-5M
Not in Commercial Distribution

  • 00816565020144 ()
IMC-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, BZO300/COC300/MTD300/OPI300/THC50
AMEDITECH INC.
IMC-5BO3
Not in Commercial Distribution

  • 00816565020137 ()
IMC-5BO3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 panel test cup, COC/OPI2000/THC
AMEDITECH INC.
IMC-3P
Not in Commercial Distribution

  • 00816565020120 ()
IMC-3P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
T001
Not in Commercial Distribution

  • 00816879021608 ()
74407

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Set of 5 Iris Retractors
AKTIVE SRL
AK-0492
In Commercial Distribution

  • 08056477550502 ()
  • 08052276027061 ()

  • GAUGE
AK-0492

  • Intraocular retractor, single-use
Set of 4 Iris Retractors
AKTIVE SRL
AK-0490
In Commercial Distribution

  • 08058340220970 ()
  • 08052276027054 ()

  • GAUGE
AK-0490

  • Intraocular retractor, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
1500BN
In Commercial Distribution

  • 00840113205042 ()
  • 00840113205059 ()


  • Skin marking pen, single-use
Set of NAVItags (sterile, single-use)
Naviswiss AG
NS010
In Commercial Distribution

  • 07640176970108 ()


  • Optical surgical navigation device tracking system
No Description
BISCO INC.
B-7350P
Not in Commercial Distribution

  • D757B7350P0 ()

  • sixe text
B-7350P

  • Dentine bonding agent/set
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