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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Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500237 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500213 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500206 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
Not in Commercial Distribution

  • 14589864500176 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500169 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500152 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500145 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500138 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500121 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500114 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500107 ()


  • Head-worn lamp
No Description
SMART MEDICAL DEVICE Co., Ltd.
DM-VME03s
Not in Commercial Distribution

  • 00193026000007 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The G5 Flimm-Fighter Percussor is the optimum percussor for effective postural drainage at home. The Flimm-Fighter incorporates Directional-Stroking action that helps loosen congestive materials and then moves them into the upper airways, thus promoting airway clearance. The red arrow on the head of the Flimm-Fighter shows the user the direction that the loosened materials are moving inside the body. The ultra-light applicator head, weighing less than one pound, allows a patient to effortlessly receive or self-administer therapy, as it is designed for use with our self application pillow*. The continuously-variable speed range of 20 - 30 cycles per second ensures that patients receive safe, thorough treatment. Comes with applicators 250, 251, 253 & 234. A pediatric version is also available. Unit Advantages: Ideal for COPD, Cystic Fibrosis, Bronchiectasis, Chronic Bronchitis, Atelectasis, Asthma, and Bronchopulmonary Dysplasia patients needing postural drainage Extremely lightweight, the Flimm-Fighter handle weighs less than 1 pound Speed: 20 - 30 cycles per second Can be used with our self application kit* and the Vari-Tilt body positioner *Self Application Kit available separately.
GENERAL PHYSIOTHERAPY INC
FF24B
In Commercial Distribution

  • 00746980000356 ()

  • Weight: 12 Pound
FF24B

  • Hand-held electric massager
No Description
Zhejiang Nysin Medical Co.,Ltd
XFGW25-203
In Commercial Distribution

  • 06977027830610 ()


  • Electric-motor-driven wheelchair, occupant-controlled
VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FT18
In Commercial Distribution

  • 30852528005323 ()
  • 10852528005329 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.018 inches
7-10026-02

  • Peripheral vascular guidewire, manual
VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .018" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FT14
In Commercial Distribution

  • 30852528005316 ()
  • 10852528005312 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
7-10026-01

  • Peripheral vascular guidewire, manual
DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO145
In Commercial Distribution

  • 10852528005282 ()

  • Crown Type, Micro
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • high speed 140 krmp
  • medium speed 90 krpm
  • low speed 60 krpm
  • Guidewirre 0.014 inches
  • shaft lengh 145 cm
  • nose lengh 7 mm
  • Crown diameter 1.25 mm
7-10024

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP–200CLASS145
In Commercial Distribution

  • 10852528005268 ()

  • Crown Type, Classic
  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 20 mm
  • Crown Diameter 2.00 mm
7-10017

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP–150CLASS145
In Commercial Distribution

  • 10852528005251 ()

  • Crown Type, Classic
  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • shaft length 145 cm
  • Nose Length 15 mm
  • Crown Diameter 1.50 mm
7-10016

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID145
In Commercial Distribution

  • 10852528005244 ()

  • Crown Type, Solid
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 7 mm
  • Crown Diameter 1.25 mm
7-10012

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150SOLID145
In Commercial Distribution

  • 10852528005237 ()

  • Crown Type, Solid
  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 10 mm
  • Crown Diameter 1.50 mm
7-10011

  • Mechanical atherectomy system catheter, peripheral
VIPERWIRE, ADVANCED, .012" DIA .012" SPRING TIP, 200CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-200
In Commercial Distribution

  • 30852528005224 ()
  • 10852528005220 ()

  • Length: 200 Centimeter
  • Max Shaft Diameter 0.012 inches
  • Max Tip Diameter 0.014 inches
7-10004

  • Peripheral vascular guidewire, manual
DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 60CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID60
In Commercial Distribution

  • 10852528005213 ()

  • Intro Sheath 4 Fr
  • Max OD 0.053 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.012 inches
  • Shaft Length 60 cm
  • Nose Length 10 mm
  • Crown Diameter 1.25 mm
  • Crown Type, Solid
7-10002

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 60CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO60
In Commercial Distribution

  • 10852528005206 ()

  • Intro Sheath 4 Fr
  • Max OD 0.053 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • guidewire size OD 0.012 inches
  • Shaft Length 60 cm
  • Nose Length 7 mm
  • Crown Size 1.25 mm
  • Crown Type, Micro
7-10001

  • Mechanical atherectomy system catheter, peripheral
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32033
Not in Commercial Distribution

  • 00842271105820 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32032
Not in Commercial Distribution

  • 00842271105813 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32031
Not in Commercial Distribution

  • 00842271105806 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32022
Not in Commercial Distribution

  • 00842271105714 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32021
Not in Commercial Distribution

  • 00842271105707 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32020
Not in Commercial Distribution

  • 00842271105691 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32209
Not in Commercial Distribution

  • 00842271105394 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32208
Not in Commercial Distribution

  • 00842271105387 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32207
Not in Commercial Distribution

  • 00842271105370 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32186
Not in Commercial Distribution

  • 00842271105165 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32152
Not in Commercial Distribution

  • 00842271104823 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32130
Not in Commercial Distribution

  • 00842271104601 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32120
Not in Commercial Distribution

  • 00842271104502 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32119
Not in Commercial Distribution

  • 00842271104496 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32110
Not in Commercial Distribution

  • 00842271104403 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32109
Not in Commercial Distribution

  • 00842271104397 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32108
Not in Commercial Distribution

  • 00842271104380 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32099
Not in Commercial Distribution

  • 00842271104298 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32098
Not in Commercial Distribution

  • 00842271104281 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32097
Not in Commercial Distribution

  • 00842271104274 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32088
Not in Commercial Distribution

  • 00842271104182 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32087
Not in Commercial Distribution

  • 00842271104175 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32086
Not in Commercial Distribution

  • 00842271104168 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32077
Not in Commercial Distribution

  • 00842271104076 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32053
Not in Commercial Distribution

  • 00842271103833 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-32043
Not in Commercial Distribution

  • 00842271103734 ()


  • Dental appliance fabrication material, ceramic
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