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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This light therapy beauty tool attacks blemishes at its core without the need for oral medications
QUASAR BIO-TECH INC.
DPA-002
In Commercial Distribution

  • 00851478007042 ()
DPA-002

  • Blue/red/infrared phototherapy lamp
Plasma Thawing System
CYTOTHERM LP
CT-D1
In Commercial Distribution

  • 00861128000354 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-DR
In Commercial Distribution

  • 00861128000347 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-D4
In Commercial Distribution

  • 00861128000330 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-4T.6C
In Commercial Distribution

  • 00861128000323 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-4T
In Commercial Distribution

  • 00861128000316 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-4S
In Commercial Distribution

  • 00861128000309 ()


  • Cryopreserved blood/tissue thawing unit
bath, paraffin
GRIMM SCIENTIFIC INDUSTRIES INC
PARATherm
In Commercial Distribution

  • 00861047000329 ()


  • Physical therapy paraffin wax bath
No Description
WR MEDICAL ELECTRONICS CO INC
TB7
In Commercial Distribution

  • 00702173123226 ()


  • Physical therapy paraffin wax bath
No Description
WR MEDICAL ELECTRONICS CO INC
TB6
In Commercial Distribution

  • 00702173123202 ()


  • Physical therapy paraffin wax bath
No Description
WR MEDICAL ELECTRONICS CO INC
TB10
In Commercial Distribution

  • 00702173122809 ()


  • Physical therapy paraffin wax bath
No Description
WR MEDICAL ELECTRONICS CO INC
TB9
In Commercial Distribution

  • 00702173122755 ()


  • Physical therapy paraffin wax bath
A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.
UPLEVITY LLC
LYFT3
In Commercial Distribution

  • 00855950007049 ()


  • Blue/red/infrared phototherapy lamp
No Description
Silhouet-Tone Corporation
411569
In Commercial Distribution

  • 00667259003895 ()


  • Blue/red/infrared phototherapy lamp
PLEGIOX Heat Exchanger, SOFTLINE coated, Sterile. The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature-controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
Maquet Cardiopulmonary AG
BO-CHX 30, SOFTLINE, Sterile
Not in Commercial Distribution

  • 04037691229591 ()
  • 04037691229584 ()
70103.4981

  • Cardiopulmonary bypass system heat exchanger, reusable
The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
Maquet Cardiopulmonary AG
CHX 30, Non-coated, Sterile
Not in Commercial Distribution

  • 04037691180038 ()
  • 04058863052267 ()

  • Total Volume: 46.885 Liter
  • Weight: 0.35 Kilogram
70103.2522

  • Cardiopulmonary bypass system heat exchanger, reusable
Plasma Thawing System
HELMER, INC.
DH2
In Commercial Distribution

  • 00816394020667 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
HELMER, INC.
DH8
In Commercial Distribution

  • 00816394020650 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
HELMER, INC.
DH4
In Commercial Distribution

  • 00816394020643 ()


  • Cryopreserved blood/tissue thawing unit
No Description
IMI Healing Technologies Inc
1
In Commercial Distribution

  • B420LEP2000PTS0 ()


  • Blue/red/infrared phototherapy lamp
No Description
IMI Healing Technologies Inc
LEP2000100D
In Commercial Distribution

  • B420LEP2000100D0 ()


  • Blue/red/infrared phototherapy lamp
No Description
IMI Healing Technologies Inc
LEP2000100C
In Commercial Distribution

  • B420LEP2000100C0 ()


  • Blue/red/infrared phototherapy lamp
No Description
IMI Healing Technologies Inc
LEP2000100B
In Commercial Distribution

  • B420LEP2000100B0 ()


  • Blue/red/infrared phototherapy lamp
No Description
IMI Healing Technologies Inc
LEP2000100A
In Commercial Distribution

  • B420LEP2000100A0 ()


  • Blue/red/infrared phototherapy lamp
No Description
IMI Healing Technologies Inc
LD100
In Commercial Distribution

  • B420LD1000 ()


  • Blue/red/infrared phototherapy lamp
No Description
SPECTRUM MEDICAL SRL
CONN-HX2
In Commercial Distribution

  • 08051160301577 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
CONN-HX1
In Commercial Distribution

  • 08051160301560 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX22W-C5
In Commercial Distribution

  • 08051160301263 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX22W-C4
In Commercial Distribution

  • 08051160301256 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX32W-C4
In Commercial Distribution

  • 08051160301249 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX22W-C1
In Commercial Distribution

  • 08051160301232 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX22W-C0
In Commercial Distribution

  • 08051160301225 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX32W-C0
In Commercial Distribution

  • 08051160301218 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX11W-S1
In Commercial Distribution

  • 08051160301201 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX11W-S0
In Commercial Distribution

  • 08051160301195 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX22W-S0
In Commercial Distribution

  • 08051160301188 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX55W-S0
In Commercial Distribution

  • 08051160301171 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX22W-S1
In Commercial Distribution

  • 08051160301003 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
FAQ™ 202 is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Foreo AB
Black
In Commercial Distribution

  • 07640260120174 ()


  • Blue/red/infrared phototherapy lamp
FAQ™ 201 is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Foreo AB
Pink Ruby
In Commercial Distribution

  • 07640260120167 ()


  • Blue/red/infrared phototherapy lamp
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