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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The X-VS sensor is intended to capture intraoral digital images when exposed to X-Rays.
CEFLA SOCIETA' COOPERATIVA
X-VS
In Commercial Distribution

  • 08033837931850 ()
XSENSONEWTOM

  • Dental digital imaging sensor, intraoral
BOT TRAY TIB/PAT CASE
Exactech, Inc.
201-55-34
In Commercial Distribution

  • 10885862043795 ()
201-55-34

  • Instrument tray, reusable
HYH SHOULDER BOT. W/CON
O&M HALYARD, INC.
05018
In Commercial Distribution

  • 30680651050183 ()
  • 10680651050189 ()
76094-ACM5018

  • Patient surgical drape, single-use
CURRETTE #6, -5DEGREE BOT BEND
Orthofix US LLC
46-1001
In Commercial Distribution

  • 18257200040094 ()


  • Metallic spinal interbody fusion cage
Salvin TG Driver
SALVIN DENTAL SPECIALTIES, LLC
TG
In Commercial Distribution

  • 00841336111530 ()
TG

  • Dental torque wrench
TG RATCHET ADAPTER
BIOMET 3I, LLC
MDR10H
Not in Commercial Distribution

  • 00844868010098 ()


  • Surgical screwdriver, reusable
IOS external fixator system (short)
METAPHYSIS LLP
2-0-0S
In Commercial Distribution

  • 05060309872017 ()


  • External orthopaedic fixation system, single-use
IOS external fixator system (Long)
METAPHYSIS LLP
2-0-0L
In Commercial Distribution

  • 05060309872000 ()


  • External orthopaedic fixation system, single-use
LOW VOL, PRE-PUMP BOT CHAMBER 6.35MM
B. BRAUN MEDICAL INC.
B3-6605M6792
Not in Commercial Distribution

  • 04046955348879 ()
  • 04046955348886 ()
B3-6605M6792

  • Haemodialysis blood tubing set, single-use
BOT TRAY FEM 2 INST CASE
Exactech, Inc.
201-55-23
In Commercial Distribution

  • 10885862238849 ()
201-55-23

  • Instrument tray, reusable
ASICO ANGLED DIAMOND CRESENT BEVEL BOT
KATENA PRODUCTS, INC.
AE-8152
In Commercial Distribution

  • 00841668141564 ()
AE-8152

  • Ophthalmic knife, reusable
INSTRUMENT 8981400 2PRNG 15DEG ZERO BOT
MEDTRONIC SOFAMOR DANEK, INC.
8981400
In Commercial Distribution

  • 00721902575570 ()


  • Orthopaedic surgical distractor, internal
CoRoent XL-F Instrument Tray (Bot Tray)
Nuvasive, Inc.
5450063
In Commercial Distribution

  • 00887517247964 ()


  • Device sterilization/disinfection container, reusable
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted GE Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082625 ()


  • MRI image interpretive software
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted On-Premise
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082618 ()
580SW.01

  • MRI image interpretive software
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted Terrarecon Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082601 ()


  • MRI image interpretive software
iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software
TG
Zoll-Dental
PC-TG
In Commercial Distribution

  • 00840105209829 ()


  • Periodontal hoe
MasterScreen IOS
Jaeger Medical GmbH
V-176420
In Commercial Distribution

  • 04250892905631 ()
V-176420

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-13
In Commercial Distribution

  • 04250892905259 ()
V-176420-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176450-13
In Commercial Distribution

  • 04250892905242 ()
176450-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
In Commercial Distribution

  • 04250892905235 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
Not in Commercial Distribution

  • 04250892900452 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176400-03
Not in Commercial Distribution

  • 04250892900438 ()
V-176400-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-376406
In Commercial Distribution

  • 04250892905808 ()
V-376406

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
Not in Commercial Distribution

  • 04250892902777 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-03
Not in Commercial Distribution

  • 04250892902760 ()
V-176420-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176400-03
Not in Commercial Distribution

  • 04250892902746 ()
V-176400-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-13
Not in Commercial Distribution

  • 04250892900513 ()
V-176420-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176450-13
Not in Commercial Distribution

  • 04250892900476 ()
176450-13

  • Pulmonary function analysis system, adult
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