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
ARUM DENTISTRY Co., Ltd.
NB15010SS
In Commercial Distribution

  • 08809917605061 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB15008SS
In Commercial Distribution

  • 08809917605054 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB14513SS
In Commercial Distribution

  • 08809917605047 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB14511SS
In Commercial Distribution

  • 08809917605030 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB14510SS
In Commercial Distribution

  • 08809917605023 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB14508SS
In Commercial Distribution

  • 08809917605016 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB14013SS
In Commercial Distribution

  • 08809917605009 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB14011SS
In Commercial Distribution

  • 08809917604996 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB14010SS
In Commercial Distribution

  • 08809917604989 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB14008SS
In Commercial Distribution

  • 08809917604972 ()


  • Screw endosteal dental implant, two-piece
No Description
HANILMEDICAL CO.,LTD.
CGM ESA-SD1501
In Commercial Distribution

  • 08800132500025 ()


  • Freestanding electric massager
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0014-0101
In Commercial Distribution

  • 04049016068792 ()


  • Enzyme immunoassay (EIA) analyser IVD
Bedside Monitor
NIHON KOHDEN CORPORATION
BSM-2301A
In Commercial Distribution

  • 04931921101629 ()


  • General-purpose multi-parameter bedside monitor
No Description
ACCUTRON, INC.
33010
In Commercial Distribution

  • 00813830021455 ()
  • 00813830027860 ()
33010

  • Anaesthesia workstation gas scavenger
No Description
I.C. MEDICAL, INC.
ICM-000-0448
In Commercial Distribution

  • 00817688021964 ()
  • 00817688021346 ()


  • Surgical plume evacuation system tube
No Description
I.C. MEDICAL, INC.
ICM-000-0295
In Commercial Distribution

  • 00817688021315 ()
  • 00817688021308 ()


  • Surgical plume evacuation system tube
No Description
I.C. MEDICAL, INC.
ICM-000-0003
In Commercial Distribution

  • 00817688021292 ()
  • 00817688021285 ()


  • Surgical plume evacuation system tube
INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is the Part A of the two part system.
RELIANCE ORTHODONTIC PRODUCTS INC
CIQA
Not in Commercial Distribution

  • D798CIQA0 ()
CIQA

  • Dentine bonding agent/set
PFT Kit I, Disposable, VBMax 36S, w/ White Foam Noseclips
A-M SYSTEMS, LLC
PFT Kit I, VBMax 36S, w/ White Foam Noseclips - 187126
In Commercial Distribution

  • 00817081026689 ()
  • 00817081026672 ()
187126

  • Pulmonary function testing kit
CS-105T-LED Colposcope Articulating Arm, Trinocular Zoom Head, Five Legged Base. LED Illumination
UNITED PRODUCTS & INSTRUMENTS
CS-105T-LED
In Commercial Distribution

  • 00816668020058 ()
CS-105T-LED

  • Colposcope
CS-105LED Colposcope Articulating Arm, Binocular Zoom Head, Five Legged Base. LED Illumination
UNITED PRODUCTS & INSTRUMENTS
CS-105LED
In Commercial Distribution

  • 00816668020041 ()
CS-105LED

  • Colposcope
CS-103T-LED Colposcope Articulating Arm, Trinocular Zoom Head, Three Legged Base. LED Illumination
UNITED PRODUCTS & INSTRUMENTS
CS-103T-LED
In Commercial Distribution

  • 00816668020034 ()
CS-103T-LED

  • Colposcope
CS-103LED Colposcope Articulating Arm, Binocular Zoom Head, Three Legged Base. LED Illumination
UNITED PRODUCTS & INSTRUMENTS
CS-103LED
In Commercial Distribution

  • 00816668020027 ()
CS-103LED

  • Colposcope
No Description
I.C. MEDICAL, INC.
2190
Not in Commercial Distribution

  • 00817688021339 ()
  • 00817688021322 ()
ICM-000-0416

  • Surgical plume evacuation system tube
UNIVERSAL S/I (STRAIGHT HANDLE), STRAIGHT GRIP SUCTION/IRRIGATION INSTRUMENT
Conmed Corporation
60-6020-115
In Commercial Distribution

  • 20653405011825 ()
  • 30653405011822 ()
  • 00653405011821 ()
60-6020-115

  • Surgical irrigation/aspiration handpiece control valve
UNIVERSAL S/I (PISTOL GRIP HANDLE), SUCTION/IRRIGATION INSTRUMENT
Conmed Corporation
60-6020-100
In Commercial Distribution

  • 20653405011795 ()
  • 30653405011792 ()
  • 00653405011791 ()
60-6020-100

  • Surgical irrigation/aspiration handpiece control valve
No Description
Hong Qiangxing (Shen Zhen) Electronics Limited
TENS
In Commercial Distribution

  • 25190119162016 ()
  • 20190119016666 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
Hong Qiangxing (Shen Zhen) Electronics Limited
TENS
In Commercial Distribution

  • 25190119016036 ()
  • 25190119165000 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
Hong Qiangxing (Shen Zhen) Electronics Limited
TENS
In Commercial Distribution

  • 25180809051010 ()
  • 05251808091010 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
Hong Qiangxing (Shen Zhen) Electronics Limited
TENS
In Commercial Distribution

  • 25180809000001 ()
  • 00251808090001 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Malar Implant
IMPLANTECH ASSOCIATES, INC.
Size 3
In Commercial Distribution

  • M724120234S1 ()
120-234S

  • Malar prosthesis
Malar Implant
IMPLANTECH ASSOCIATES, INC.
Size 2
In Commercial Distribution

  • M724120224S1 ()
120-224S

  • Malar prosthesis
Malar Implant
IMPLANTECH ASSOCIATES, INC.
Size 1
In Commercial Distribution

  • M724120214S1 ()
120-214S

  • Malar prosthesis
No Description
CLASSYS Inc.
VLMC02501
Not in Commercial Distribution

  • 08800016902730 ()


  • Radio-frequency skin contouring system applicator tip
Serology I Postive Control is intended for use with in vitro assays for determination of antibodies to Human Immunodeficiency Virus Type 1 and 2 (HIV-1/2), antibodies to Human T-Lymphotropic Virus Type 1 and 2 (HTLV-1/2), antibodies to Hepatitis C Virus (HCV), Hepatitis B Surface Antigen (HBsAg), IgG antibodies to Hepatitis B Core Antibodies (HBc) and IgG antibodies to Treponema pallidum. Serology I Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. Serology I Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10352
In Commercial Distribution

  • 05055273216509 ()
SR10352

  • Multiple-type blood-borne pathogen antibody/antigen IVD, control
No Description
MEDIVANCE INSTRUMENTS LIMITED
MK5
In Commercial Distribution

  • 05060209580012 ()
I/MAC8502F /I/MAC8503F /I/MAC8508F

  • Dental abrasive air jet system
DBS PART I ELECTRODE INSERT PK
Cardinal Health 200, LLC
SNE51DBU14
In Commercial Distribution

  • 50195594115478 ()
  • 10195594115470 ()
SNE51DBU14

  • Neurosurgical procedure kit, non-medicated, single-use
DBS PART I ELECTRODE INSERT PK
MEDLINE INDUSTRIES, INC.
DYNJ67360B
In Commercial Distribution

  • 40195327677016 ()
  • 10195327677015 ()
DYNJ67360B

  • General surgical procedure kit, non-medicated, single-use
DBS PART I ELECTRODE INSERT PK
Cardinal Health 200, LLC
SNE51DBU13
In Commercial Distribution

  • 50195594060525 ()
  • 10195594060527 ()
SNE51DBU13

  • Neurosurgical procedure kit, non-medicated, single-use
Seibel I Flap Lifter & Retreatment Spat
KATENA PRODUCTS, INC.
08-16172
In Commercial Distribution

  • 00852979003472 ()
08-16172

  • Ophthalmic surgical probe, reusable
KOVA-Trol I: High Abnormal (4x60 mL)
KOVA INTERNATIONAL, INC.
87325E
In Commercial Distribution

  • 00855617006217 ()
87325E

  • Urine sediment IVD, control
KOVA-Trol I: High Abnormal (4x15 mL)
KOVA INTERNATIONAL, INC.
87329E
In Commercial Distribution

  • 00855617006200 ()
87329E

  • Urine sediment IVD, control
TOTAL JOINT PACK I AND II
MEDLINE INDUSTRIES, INC.
DYNJ68701
In Commercial Distribution

  • 10193489841930 ()
DYNJ68701

  • General surgical procedure kit, non-medicated, single-use
DBS PART I ELECTRODE INSERT PK
MEDLINE INDUSTRIES, INC.
DYNJ67360
In Commercial Distribution

  • 40193489886307 ()
  • 10193489886306 ()
DYNJ67360

  • General surgical procedure kit, non-medicated, single-use
Single Procedure Kit w/ Pad I
SPR THERAPEUTICS, INC.
PNS System
In Commercial Distribution

  • 00854001007366 ()
9243

  • Analgesic PENS system
KIT STC ORTHO I & D ADD-ON
MEDLINE INDUSTRIES, INC.
DYKMBNDL44A
In Commercial Distribution

  • 40193489867115 ()
  • 10193489867114 ()
DYKMBNDL44A

  • General surgical procedure kit, non-medicated, single-use
Control Body,Air SE,Pac I
A-DEC, INC.
12.0797.00
In Commercial Distribution

  • 10194665005290 ()
12.0797.00

  • Dental suction system
"OFD1-03 Ofodile Series I Silicone Implants"
SURGICAL TECHNOLOGY LABORATORIES INC
OFD1-03
In Commercial Distribution

  • 00851988007624 ()
OFD1-03

  • Nasal cartilage support implant, non-bioabsorbable
"OFD1-02 Ofodile Series I Silicone Implants"
SURGICAL TECHNOLOGY LABORATORIES INC
OFD1-02
In Commercial Distribution

  • 00851988007617 ()
OFD1-02

  • Nasal cartilage support implant, non-bioabsorbable
"OFD1-01 Ofodile Series I Silicone Implants"
SURGICAL TECHNOLOGY LABORATORIES INC
OFD1-01
In Commercial Distribution

  • 00851988007600 ()
OFD1-01

  • Nasal cartilage support implant, non-bioabsorbable
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