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
JK-Products GmbH
JK 98 / 48-0
In Commercial Distribution

  • EJKP100003334A0 ()


  • Vibration platform exerciser, stationary
  • Ultraviolet tanning device
No Description
JK-Products GmbH
JK 98 / 48-0
In Commercial Distribution

  • EJKP100003333A0 ()


  • Vibration platform exerciser, stationary
  • Ultraviolet tanning device
Dental Mandrel
DEN-MAT HOLDINGS, LLC
078208
In Commercial Distribution

  • 00359883003104 ()
078208

  • Dental abrasive point, reusable
Dental Mandrel
DEN-MAT HOLDINGS, LLC
078206
In Commercial Distribution

  • 00359883003098 ()
078206

  • Dental abrasive point, reusable
Dental Mandrel
DEN-MAT HOLDINGS, LLC
078205
In Commercial Distribution

  • 00359883003081 ()
078205

  • Dental abrasive point, reusable
No Description
AB MEDICA
LIL-IP-2DS-20
In Commercial Distribution

  • E496LILIP2DS200 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
No Description
AB MEDICA
C05-IP-2DS-50
In Commercial Distribution

  • E496C05IP2DS500 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
No Description
AB MEDICA
C05-IP-2DS-35
In Commercial Distribution

  • E496C05IP2DS350 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
No Description
AB MEDICA
C05-IP-2DC-50
In Commercial Distribution

  • E496C05IP2DC500 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
No Description
AB MEDICA
C05-IP-2DC-35
In Commercial Distribution

  • E496C05IP2DC350 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078208
In Commercial Distribution

  • 07540172001458 ()
078208

  • Dental abrasive point, reusable
Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078206
In Commercial Distribution

  • 07540172001441 ()
078206

  • Dental abrasive point, reusable
Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078205
In Commercial Distribution

  • 07540172001434 ()
078205

  • Dental abrasive point, reusable
Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078204
In Commercial Distribution

  • 07540172001427 ()
078204

  • Dental abrasive point, reusable
Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078202
Not in Commercial Distribution

  • 07540172001410 ()
078202

  • Dental abrasive point, reusable
Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078201
Not in Commercial Distribution

  • 07540172001403 ()
078201

  • Dental abrasive point, reusable
The kinderBAND™ cranial remolding orthosis is a custom made orthotic device available by prescription only. It is used to treat infants between 3 and 18 months of age for asymmetrical head shapes such as positional plagiocephaly, brachycephaly and scaphocephaly.
BIOSCULPTOR CORPORATION
CL-4000
In Commercial Distribution

  • 00863457000302 ()
CL-4000

  • Cranial orthosis
The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads.
DANMAR PRODUCTS INC
9841
In Commercial Distribution

  • 00862948000302 ()


  • Cranial orthosis
Cranial Remolding Orthosis
Surestep, LLC
A8210
In Commercial Distribution

  • 00859065006034 ()


  • Cranial orthosis
Cranial Remolding Orthosis
Symbiont Logistics, LLC
A8210
In Commercial Distribution

  • 00859065006027 ()


  • Cranial orthosis
Cranial Remolding Orthosis
HANGER NATRIONAL LABORATORIES LLC
F8210
In Commercial Distribution

  • 00859065006003 ()


  • Cranial orthosis
Boston Band custom cranial remolding orthosis
Boston Brace International, Inc.
BB1
In Commercial Distribution

  • 00860010708101 ()


  • Cranial orthosis
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.
INVENT MEDICAL USA LLC
Talee PostOp w/2in1/Bi-Valve Opening
In Commercial Distribution

  • 00860013898076 ()


  • Cranial orthosis
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.
INVENT MEDICAL USA LLC
Talee PostOp w/2in1/One-Side Opening
In Commercial Distribution

  • 00860013898069 ()


  • Cranial orthosis
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.
INVENT MEDICAL USA LLC
Talee PostOp w/Bi-Valve Opening
In Commercial Distribution

  • 00860013898052 ()


  • Cranial orthosis
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.
INVENT MEDICAL USA LLC
Talee PostOp w/One-Side Opening
In Commercial Distribution

  • 00860013898045 ()


  • Cranial orthosis
The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects.
INVENT MEDICAL USA LLC
Talee w/2in1/One-Side Opening
In Commercial Distribution

  • 00860013898021 ()


  • Cranial orthosis
The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects.
INVENT MEDICAL USA LLC
Talee w/One-Side Opening
In Commercial Distribution

  • 00860013898007 ()


  • Cranial orthosis
The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects.
INVENT MEDICAL USA LLC
Talee w/2in1/Bi-Valve Opening
In Commercial Distribution

  • 00860013898038 ()


  • Cranial orthosis
The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects.
INVENT MEDICAL USA LLC
Talee w/Bi-Valve Opening
In Commercial Distribution

  • 00860013898014 ()


  • Cranial orthosis
MyCRO Band w/Lining beige
OTTO BOCK HEALTHCARE
24H1=9
In Commercial Distribution

  • 04064409000104 ()


  • Cranial orthosis
MyCRO Band w/Lining brown
OTTO BOCK HEALTHCARE
24H1=8
In Commercial Distribution

  • 04064409000098 ()


  • Cranial orthosis
MyCRO Band w/Lining black
OTTO BOCK HEALTHCARE
24H1=7
In Commercial Distribution

  • 04064409000081 ()


  • Cranial orthosis
MyCRO Band w/Lining blue
OTTO BOCK HEALTHCARE
24H1=5
In Commercial Distribution

  • 04064409000074 ()


  • Cranial orthosis
MyCRO Band w/Lining green
OTTO BOCK HEALTHCARE
24H1=3
In Commercial Distribution

  • 04064409000067 ()


  • Cranial orthosis
MyCRO Band w/Lining dark red
OTTO BOCK HEALTHCARE
24H1=2.5
In Commercial Distribution

  • 04064409000050 ()


  • Cranial orthosis
MyCRO Band w/Lining orange
OTTO BOCK HEALTHCARE
24H1=13
In Commercial Distribution

  • 04064409000043 ()


  • Cranial orthosis
MyCRO Band w/Lining pink
OTTO BOCK HEALTHCARE
24H1=12
In Commercial Distribution

  • 04064409000036 ()


  • Cranial orthosis
MyCRO Band w/Lining purple
OTTO BOCK HEALTHCARE
24H1=11
In Commercial Distribution

  • 04064409000029 ()


  • Cranial orthosis
MyCRO Band w/Lining grey
OTTO BOCK HEALTHCARE
24H1=1
In Commercial Distribution

  • 04064409000012 ()


  • Cranial orthosis
P-POD Plagiocephaly Helmet is a Class II cranial orthosis intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads. The P-POD helmet is similar to the predicate devices in such that it is an orthosis designed for each patient from a cast of the infant's head. Each orthosis is composed on an outer shell with a layer of foam and a side strap for securing the orthosis. Additionally, the helmet has a top vent and side opening as typically seen with the predicates. Optimum fit and alignment is insured and monitored by the clinical practitioner.
PPOD Orthotics Inc.
DD-1930
In Commercial Distribution

  • 00196852667895 ()
DD-1930

  • Cranial orthosis
Eye-Safe Laser Data Acquisition System that collects 3-D infant’s head shape data which is used for the fabrication of cranial orthoses.
Vorum Research Corporation
Series B
In Commercial Distribution

  • B590507012000 ()
50-7012-00

  • Cranial orthosis
The STARband® is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARband® is made with an outer copolymer plastic shell and an inner liner made of pelite polyethylene foam or Aliplast foam (closed cell polyethylene). It utilizes a side opening design and is held in place by a Velcro® strap across the side opening.
ORTHOMERICA PRODUCTS, INC.
766PA
In Commercial Distribution

  • B151766PA0 ()
766PA

  • Cranial orthosis
The STARband® is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARband® is made with an outer copolymer plastic shell and an inner liner made of pelite polyethylene foam or Aliplast foam (closed cell polyethylene). It utilizes a side opening design and is held in place by a Velcro® strap across the side opening.
ORTHOMERICA PRODUCTS, INC.
766A
In Commercial Distribution

  • B151766A0 ()
766A

  • Cranial orthosis
The STARband® 3D is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape.
ORTHOMERICA PRODUCTS, INC.
766.10A
In Commercial Distribution

  • B15176610A0 ()
766.10A

  • Cranial orthosis
The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.
ORTHOMERICA PRODUCTS, INC.
766.09PA
In Commercial Distribution

  • B15176609PA0 ()
766.09PA

  • Cranial orthosis
The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.
ORTHOMERICA PRODUCTS, INC.
766.09A
In Commercial Distribution

  • B15176609A0 ()
766.09A

  • Cranial orthosis
The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARlight® PRO is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding and/or Reston (polyurethane) foam. It utilizes two side openings and is held in place by a Velcro® straps across the side openings.
ORTHOMERICA PRODUCTS, INC.
766.07PA
In Commercial Distribution

  • B15176607PA0 ()
766.07PA

  • Cranial orthosis
The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARband® Bi-Valve is made with an outer copolymer plastic shell and an inner liner made of pelite polyethylene foam or Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
766.06PA
In Commercial Distribution

  • B15176606PA0 ()
766.06PA

  • Cranial orthosis
The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARband® Bi-Valve is made with an outer copolymer plastic shell and an inner liner made of pelite polyethylene foam or Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
766.06A
In Commercial Distribution

  • B15176606A0 ()
766.06A

  • Cranial orthosis
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