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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Classic Dental System
ASI MEDICAL, INC.
90-2045
In Commercial Distribution

  • 00850309007022 ()
90-2045

  • Dental delivery system instrument unit, electric
Classic Assistant's System
ASI MEDICAL, INC.
90-1045
In Commercial Distribution

  • 00850309007015 ()
90-1045

  • Dental delivery system instrument unit, electric
Classic Assistant's System
ASI MEDICAL, INC.
90-1044
In Commercial Distribution

  • 00850309007008 ()
90-1044

  • Dental delivery system instrument unit, electric
Integrated delivery system with up to two handpiece connections, dual air/water syringes and titanium saliva ejector and high-volume evacuator. Delivery system features programmable electro-mechanically adjusted height to allow for sit down to stand up procedures and Wilsonart solid surface worktop and heavy duty 3” casters. Storage includes two side rails for accessory brackets, saline bag hooks, and sharps containers. Includes back rail with two storage tubs.
ASI MEDICAL, INC.
90-2148
Not in Commercial Distribution

  • 00850309007770 ()


  • Dental delivery system instrument unit, electric
Advanced Dental/ Endodontics Systems - Umbilical Cart
ASI MEDICAL, INC.
90-2143DS
In Commercial Distribution

  • 00850309007763 ()


  • Dental delivery system instrument unit, electric
Light based, over the counter device intended for the removal of unwanted hair as well as permanent reduction in hair regrowth.
BEURER NORTH AMERICA, L.P.
IPL7500 (Art.-No. 575.71)
In Commercial Distribution

  • 10852547004730 ()
  • 00852547004733 ()


  • Intense pulsed light skin surface treatment system
Light based, over the counter device intended for the removal of unwanted hair as well as permanent reduction in hair regrowth.
BEURER NORTH AMERICA, L.P.
IPL100 (Art.-No. 575.40)
In Commercial Distribution

  • 10852547004495 ()
  • 00852547004498 ()
Art.-No. 575.40

  • Intense pulsed light skin surface treatment system
A-dec CART343pro Cart Delivery System
A-DEC, INC.
343pro
In Commercial Distribution

  • 10194665007300 ()
343pro

  • Dental delivery system instrument unit, electric
The Sensilight Pro is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured 6, 9 and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL300US04SNS
In Commercial Distribution

  • 05060445341576 ()


  • Intense pulsed light skin surface treatment system
The Sensilight Mini is an over the counter device intended for the removal of unwanted hair. The Sensilight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL030US05SNS
In Commercial Distribution

  • 05060445341569 ()


  • Intense pulsed light skin surface treatment system
The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL030US02SNS
In Commercial Distribution

  • 05060445340050 ()


  • Intense pulsed light skin surface treatment system
The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL030US01SNS
In Commercial Distribution

  • 05060445340043 ()


  • Intense pulsed light skin surface treatment system
The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL050US02SNS
In Commercial Distribution

  • 05060445340029 ()


  • Intense pulsed light skin surface treatment system
The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL050US03SNS
In Commercial Distribution

  • 05060445340012 ()


  • Intense pulsed light skin surface treatment system
The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL050US01SNS
In Commercial Distribution

  • 05060445340005 ()


  • Intense pulsed light skin surface treatment system
MDElite iProX - Intense Pulsed Light Equipment - AC110V 50/60Hz 2500VA 34*57*118cm 62kg - FDA 510(k) K193328
MDElite Laser and Aesthetic, LLC
iProX
In Commercial Distribution

  • 00860007876806 ()


  • Intense pulsed light skin surface treatment system
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro+
In Commercial Distribution

  • 06944843655895 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro
In Commercial Distribution

  • 06944843655888 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5+
In Commercial Distribution

  • 06944843655871 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5
In Commercial Distribution

  • 06944843655864 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro+
In Commercial Distribution

  • 06944843655857 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro
In Commercial Distribution

  • 06944843655840 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5+
In Commercial Distribution

  • 06944843655833 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5
In Commercial Distribution

  • 06944843655826 ()


  • Dental delivery system instrument unit, electric
Dental delivery system instrument unit, electric
Guilin Woodpecker Medical Instrument Co., Ltd.
MT3
In Commercial Distribution

  • 06944843611563 ()


  • Dental delivery system instrument unit, electric
Dental delivery system instrument unit, electric
Guilin Woodpecker Medical Instrument Co., Ltd.
MT3
In Commercial Distribution

  • 06944843611518 ()


  • Dental delivery system instrument unit, electric
Dental delivery system instrument unit, electric
Guilin Woodpecker Medical Instrument Co., Ltd.
MT2
In Commercial Distribution

  • 06944843611488 ()


  • Dental delivery system instrument unit, electric
Dental delivery system instrument unit, electric
Guilin Woodpecker Medical Instrument Co., Ltd.
MT3
In Commercial Distribution

  • 06944843611259 ()


  • Dental delivery system instrument unit, electric
Cabinet Mounted Assistant's Unit that includes HVE, Saliva Ejector and Syringe.
MIDMARK CORPORATION
002-1879-00
In Commercial Distribution

  • 00841709118739 ()
002-1879-00

  • Dental delivery system instrument unit, electric
DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications.
DIAGNOSTIC GRIFOLS SA
213734
In Commercial Distribution

  • 08437014205169 ()
213734

  • Microplate/tube/assay card incubator IVD
IPS
BIO-RAD
87530
In Commercial Distribution

  • 03610520014103 ()

  • 1 each
87530

  • Microplate/tube/assay card incubator IVD
Maxima-iL Implant HP F/O
HENRY SCHEIN, INC.
5701448
In Commercial Distribution

  • 00304040110867 ()
5701448

  • Dental delivery system instrument unit, electric
Maxima-i Implant Handpiece N/O
HENRY SCHEIN, INC.
5701447
In Commercial Distribution

  • 00304040110850 ()
5701447

  • Dental delivery system instrument unit, electric
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect-10PL Handpiece
TENTECH Inc.
10PL-H/P
In Commercial Distribution

  • 08809709380435 ()


  • Intense pulsed light skin surface treatment system
Powered Light based Non-Laser Surgical Instrument With Thermal Effect
TENTECH Inc.
10PL-Body
In Commercial Distribution

  • 08809709380411 ()


  • Intense pulsed light skin surface treatment system
Posterior CleanFlow Procedure Instrument with Matrices (Singles)
SONENDO, INC.
FG-013-00004
Not in Commercial Distribution

  • 00195893912278 ()
GW-PST-PI01

  • Dental delivery system instrument unit, electric
Midmark Procenter Rear Chair Hub Mounted (Midmark Elevance Chairs) Assistant's Unit Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
MIDMARK CORPORATION
153604LR-E
In Commercial Distribution

  • 00841709110382 ()
153604LR-E

  • Dental delivery system instrument unit, electric
Midmark Procenter LR Concept (Midmark Elevance Chairs) Cuspidor and Assistant's Combination Unit Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
MIDMARK CORPORATION
153604LRCA-E
In Commercial Distribution

  • 00841709110375 ()
153604LRCA-E

  • Dental delivery system instrument unit, electric
Midmark Procenter LR Concept (Midmark Ultra Chairs) Cuspidor and Assistant's Combination Unit Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
MIDMARK CORPORATION
153604LRCA
In Commercial Distribution

  • 00841709110368 ()
153604LRCA

  • Dental delivery system instrument unit, electric
Midmark Procenter Rear Chair Hub Mounted (Midmark Ultra Chairs) Assistant's Unit Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
MIDMARK CORPORATION
153604LR
In Commercial Distribution

  • 00841709110351 ()
153604LR

  • Dental delivery system instrument unit, electric
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