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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1299-00-16
Pajunk GmbH Medizintechnologie
1299-00-16
In Commercial Distribution

1299-00-16

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
1299-00-15
Pajunk GmbH Medizintechnologie
1299-00-15
In Commercial Distribution

1299-00-15

  • Haemostatic knife
1299-00-14
Pajunk GmbH Medizintechnologie
1299-00-14
In Commercial Distribution

1299-00-14

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
1299-00-13
Pajunk GmbH Medizintechnologie
1299-00-13
In Commercial Distribution

1299-00-13

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
1299-00-12
Pajunk GmbH Medizintechnologie
1299-00-12
In Commercial Distribution

1299-00-12

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
1299-00-11
Pajunk GmbH Medizintechnologie
1299-00-11
In Commercial Distribution

1299-00-11

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
ENACEM HF+BONDING COMPLETE KIT 1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5 COSM3A-1 ORANGE NEEDLETUBE 20 gauge 5 COSM3P-1 PLUG for NEEDLETUBE 20 gauge 1 CPC-3UD1 ENACEM HF DUAL CEMENT UD1 3g 1 CPC-3UD2 ENACEM HF DUAL CEMENT UD2 3g 1 CPC-3UD3 ENACEM HF DUAL CEMENT UD3 3g 1 CPC-3UD4 ENACEM HF DUAL CEMENT UD4 3g 5 CPCTIPL-1 White Syringe needle 8 CPCTIPN-1 AUTOMIX ENACEM needle 4 CPCTIPS-1 Intraoral Syringe Needle
MICERIUM SPA
CPCK
In Commercial Distribution

  • EMICCPCK1 ()
CPCK

  • Glass ionomer dental cement
  • Dental prosthesis-component adhesive
SafeSiders HF Gutta Percha 30/04
ESSENTIAL DENTAL SYSTEMS, INC.
5104-G30
In Commercial Distribution

  • 00766054002833 ()
5104-G30

  • Root canal obturating point
SafeSiders HF Gutta Percha 25/04
ESSENTIAL DENTAL SYSTEMS, INC.
5104-G25
In Commercial Distribution

  • 00766054002826 ()
5104-G25

  • Root canal obturating point
Safesider HF Glidepath Refill 25 mm
ESSENTIAL DENTAL SYSTEMS, INC.
5125-01
In Commercial Distribution

  • 00766054002819 ()
5125-01

  • Rotary/reciprocating endodontic file/rasp, reusable
Safesider HF Shaper Refill 25 mm
ESSENTIAL DENTAL SYSTEMS, INC.
5125-02
In Commercial Distribution

  • 00766054002802 ()
5125-02

  • Rotary/reciprocating endodontic file/rasp, reusable
Safesider HF Finisher Refill 25 mm
ESSENTIAL DENTAL SYSTEMS, INC.
5125-03
In Commercial Distribution

  • 00766054002796 ()
5125-03

  • Rotary/reciprocating endodontic file/rasp, reusable
Safesider HF Finisher Refill 21 mm
ESSENTIAL DENTAL SYSTEMS, INC.
5121-03
In Commercial Distribution

  • 00766054002789 ()
5121-03

  • Rotary/reciprocating endodontic file/rasp, reusable
Safesider HF Shaper Refill 21 mm
ESSENTIAL DENTAL SYSTEMS, INC.
5121-02
In Commercial Distribution

  • 00766054002772 ()
5121-02

  • Rotary/reciprocating endodontic file/rasp, reusable
Safesider HF Glidepath Refill 21 mm
ESSENTIAL DENTAL SYSTEMS, INC.
5121-01
In Commercial Distribution

  • 00766054002765 ()
5121-01

  • Rotary/reciprocating endodontic file/rasp, reusable
Safesider HF Intro Kit 25 mm
ESSENTIAL DENTAL SYSTEMS, INC.
5125-123
In Commercial Distribution

  • 00766054002758 ()
5125-123

  • Rotary/reciprocating endodontic file/rasp, reusable
Safesider HF Intro Kit 21 mm
ESSENTIAL DENTAL SYSTEMS, INC.
5121-123
In Commercial Distribution

  • 00766054002741 ()
5121-123

  • Rotary/reciprocating endodontic file/rasp, reusable
XCALIBUR ACQUISITION BREAKOUT
XLTEK
10359
In Commercial Distribution

  • 00382830002950 ()


  • Electromyograph
RECOVERY PARTNER ACQUISITION
MEDLINE INDUSTRIES, INC.
DYNDA2336A
In Commercial Distribution

  • 40193489364119 ()
  • 10193489364118 ()
DYNDA2336A

  • General surgical procedure kit, non-medicated, single-use
EEG Acquisition Kit
NIHON KOHDEN CORPORATION
QP-931BK
In Commercial Distribution

  • 04931921119761 ()


  • Evoked-potential graphic recording system
Data acquisition unit
NIHON KOHDEN CORPORATION
JA-694PA
In Commercial Distribution

  • 04931921102824 ()
JA-694PA

  • General-purpose multi-parameter bedside monitor
Data acquisition unit
NIHON KOHDEN CORPORATION
JA-690PA
In Commercial Distribution

  • 04931921102800 ()
JA-690PA

  • General-purpose multi-parameter bedside monitor
POST ACQUISITION PROCESSING
MEDLINE INDUSTRIES, INC.
DYNJ64438
In Commercial Distribution

  • 10193489200355 ()
DYNJ64438

  • General surgical procedure kit, non-medicated, single-use
POST ACQUISITION PROCESSING
MEDLINE INDUSTRIES, INC.
DYNJ64438A
In Commercial Distribution

  • 10193489242195 ()
  • 40193489242196 ()
DYNJ64438A

  • General surgical procedure kit, non-medicated, single-use
Data acquisition unit
NIHON KOHDEN AMERICA, INC.
JA-694PA
In Commercial Distribution

  • 00841983100536 ()
JA-694PA

  • General-purpose multi-parameter bedside monitor
RECOVERY PARTNER ACQUISITION
MEDLINE INDUSTRIES, INC.
DYNDA2907A
In Commercial Distribution

  • 40195327300778 ()
  • 10195327300777 ()
DYNDA2907A

  • General surgical procedure kit, non-medicated, single-use
RECOVERY PARTNER ACQUISITION
MEDLINE INDUSTRIES, INC.
DYNDA2336
In Commercial Distribution

  • 10889942735174 ()
DYNDA2336

  • General surgical procedure kit, non-medicated, single-use
RECOVERY PARTNER ACQUISITION
MEDLINE INDUSTRIES, INC.
DYNDA2336B
In Commercial Distribution

  • 40195327320301 ()
  • 10195327320300 ()
DYNDA2336B

  • General surgical procedure kit, non-medicated, single-use
RECOVERY PARTNER ACQUISITION
MEDLINE INDUSTRIES, INC.
DYNDA2907
In Commercial Distribution

  • 40195327069750 ()
  • 10195327069759 ()
DYNDA2907

  • General surgical procedure kit, non-medicated, single-use
Right acquisition cable
ALPHATEC SPINE, INC.
200575-SS
In Commercial Distribution

  • 00190376189130 ()


  • Electrical-only medical device connection cable, single-use
Left acquisition cable
ALPHATEC SPINE, INC.
200574-SS
In Commercial Distribution

  • 00190376189123 ()


  • Electrical-only medical device connection cable, single-use
PLACENTA ACQUISITION KIT
DEROYAL INDUSTRIES, INC.
89-10637
In Commercial Distribution

  • 50749756370658 ()
  • 00749756370653 ()
89-10637

  • General surgical procedure kit, non-medicated, single-use
Coronary Guidewire
CONCERT MEDICAL, LLC
HF J
In Commercial Distribution

  • 00814384020277 ()
  • 00814384020260 ()
389782

  • Cardiac/peripheral vascular guidewire, single-use
PODIATRY X-RAY MACHINE, 10-18mA, 50-90 kV
ARQUILLA, INC.
HF 718BD
In Commercial Distribution

  • B216HF718BD1 ()


  • Stationary basic diagnostic x-ray system, analogue
No Description
MPS MEDICAL, INC
HF .22
In Commercial Distribution

  • 00816513021636 ()
  • 10816513021633 ()


  • Medication transfer set
PHF UVA CL 10L
DAAVLIN DISTRIBUTING CO., THE
Phothera HF
In Commercial Distribution

  • 00810182930527 ()


  • Ultraviolet phototherapy unit, professional
PHF NBUVB CL 10L
DAAVLIN DISTRIBUTING CO., THE
Phothera HF
In Commercial Distribution

  • 00810182930510 ()


  • Ultraviolet phototherapy unit, professional
PHF NBUVB DT 10L
DAAVLIN DISTRIBUTING CO., THE
Phothera HF
In Commercial Distribution

  • 00810182930503 ()


  • Ultraviolet phototherapy unit, professional
PHF NBUVB CT 10L
DAAVLIN DISTRIBUTING CO., THE
Phothera HF
In Commercial Distribution

  • 00810182930497 ()


  • Ultraviolet phototherapy unit, professional
PIEZON® 150
E.M.S. Electro Medical Systems S.A.
FT-215/HF
In Commercial Distribution

  • 07613353195939 ()


  • Ultrasonic dental scaling/debridement system
PIEZON® 250
E.M.S. Electro Medical Systems S.A.
FT-216HF/HF
In Commercial Distribution

  • 07613353184896 ()


  • Ultrasonic dental scaling/debridement system
Additional flow heater unit for AquaBplus Water Treatment Systems. AquaBplus HF Unit for: AquaBplus & AquaBplus HF 500 (Primary DI No.: 04251285200128) AquaBplus & AquaBplus HF 1000 (Primary DI No.: 04251285200135) AquaBplus & AquaBplus HF 1500 (Primary DI No.: 04251285200142) AquaBplus & AquaBplus HF 2000 (Primary DI No.: 04251285200159) AquaBplus & AquaBplus HF 2500 (Primary DI No.: 04251285200166) AquaBplus & AquaBplus HF 3000 (Primary DI No.: 04251285200173) AquaBplus & AquaBplus B2 & AquaBplus HF 500 (Primary DI No.: 04251285200180) AquaBplus & AquaBplus B2 & AquaBplus HF 1000 (Primary DI No.: 04251285200197) AquaBplus & AquaBplus B2 & AquaBplus HF 1500 (Primary DI No.: 04251285200203) AquaBplus & AquaBplus B2 & AquaBplus HF 2000 (Primary DI No.: 04251285200210) AquaBplus & AquaBplus B2 & AquaBplus HF 2500 (Primary DI No.: 04251285200227)
VIVONIC GmbH
AquaBplus HF
In Commercial Distribution

  • 04251285200296 ()


  • Reverse-osmosis water purification system
No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1279.HF
In Commercial Distribution

  • 08717872018546 ()
  • 18717872018543 ()
1279.HF

  • Ophthalmic cannulation set, single-use
MIDDLE EAR ANALYZER. Flute HF is a middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, ETF (Eustachian Tube Function) test for both intact and perforated eardrums, and tympanometry at 1000 Hz.
INVENTIS SRL
FLUTE HF
In Commercial Distribution

  • 08054187380440 ()
10409

  • Impedance audiometer
HF Ibramed is a portable high frequency piece of equipment for facial, body, capillary and podology application. Application frequency is monopolar, that is, only one electrode is used. The function of the gas inside the electrode is to induce the current flow. This gas is excited through the passage of electric current and produces a light, whose color depends on the type of gas used. The gas is then ionized by the high tension, making the glass bulb fluorescent.
Ibramed Industria Brasileira de Equipamentos Medicos Eir
HF IBRAMED
In Commercial Distribution

  • 07898961579146 ()
1007011

  • Professional hair-removal electrolysis system
LUM LAM CUSTOM PACK F/ CO CUSTOM
HENRY SCHEIN, INC.
5702914
In Commercial Distribution

  • 00304040168257 ()
  • 10304040168254 ()
5702914

  • General surgical procedure kit, non-medicated, single-use
*Custom* Kent CO DE IV Start Kit
BOUND TREE MEDICAL, LLC
8600-01437
In Commercial Distribution

  • 00812277036145 ()
8600-01437

  • Peripheral intravenous catheterization support kit
KIT DECOMPRESSION KIT FOR QUEEN ANNE'S CO
BOUND TREE MEDICAL, LLC
QASEEPNEK
In Commercial Distribution

  • 00812277033748 ()
QASEEPNEK

  • Pneumothorax catheter insertion set
KUP2 KOIS UNIV CO (M) FL 3P
Peter Brasseler Holdings, LLC
5030930U0
In Commercial Distribution

  • 00887919964988 ()


  • Dental abrasive point, reusable
KIT,ANE UNIV OF CO 30 CS
Cardinal Health 200, LLC
ANE4588111
In Commercial Distribution

  • 50887488981725 ()
  • 10887488981727 ()
ANE4588111

  • General surgical procedure kit, non-medicated, single-use
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