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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Labelled with CE
KOBOLD, LLC
813-000
In Commercial Distribution

  • 00815568020892 ()


  • Needle guide, single-use
K-Wire with Stop
Stryker GmbH
705150
In Commercial Distribution

  • 07613327398885 ()

  • Length: 150.0 Millimeter
  • Diameter: 1.6 Millimeter
705150

  • Orthopaedic intraoperative positioning pin, single-use
Software with CardioStation
UNIVERSAL MEDICAL, INC.
eCardiostation Software
In Commercial Distribution

  • B147EC0 ()


  • Electrocardiography telemetric monitoring system
Wedge with Tail
Hovertech International
PROS-TAIL
In Commercial Distribution

  • 00816299012750 ()
  • 00816299012736 ()
  • 00816299012774 ()
PROS-TAIL

  • Freestanding patient positioner, single-use
Base with Anatite
KEYSTONE DENTAL, INC.
45009K
Not in Commercial Distribution

  • D76845009K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45009K

  • Dental implant suprastructure, permanent, preformed
Base with Anatite
KEYSTONE DENTAL, INC.
45008K
Not in Commercial Distribution

  • D76845008K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45008K

  • Dental implant suprastructure, permanent, preformed
Base with Anatite
KEYSTONE DENTAL, INC.
45007K
Not in Commercial Distribution

  • D76845007K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45007K

  • Dental implant suprastructure, permanent, preformed
Adhesive with hydrogel
Medidata Solutions, Inc.
BRCA02
In Commercial Distribution

  • G012MC0009 ()
  • G012BRCA02 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
Standard with grip
Advanced Bionics AG
CI-5711-210
Not in Commercial Distribution

  • 07630016880773 ()


  • Cochlear implant/auditory brainstem implant sound processor earhook
Small with grip
Advanced Bionics AG
CI-5711-200
Not in Commercial Distribution

  • 07630016880766 ()


  • Cochlear implant/auditory brainstem implant sound processor earhook
Standard with grip
Advanced Bionics AG
CI-5710-210
Not in Commercial Distribution

  • 07630016851193 ()


  • Cochlear implant/auditory brainstem implant sound processor
Small with grip
Advanced Bionics AG
CI-5710-110
Not in Commercial Distribution

  • 07630016851186 ()


  • Cochlear implant/auditory brainstem implant sound processor
FiberTak with SutureTape
ARTHREX, INC.
AR-3602-1
In Commercial Distribution

  • 00888867287099 ()
AR-3602-1

  • Tendon/ligament bone anchor, non-bioabsorbable
COBB WITH SUCTION
ARTHREX, INC.
AR-9260-60
In Commercial Distribution

  • 00888867285156 ()
AR-9260-60

  • Drilling power tool attachment, basic
Multi-Driver with T-Handle
ARTHREX, INC.
AR-8964-23
In Commercial Distribution

  • 00888867241428 ()
AR-8964-23

  • Orthopaedic implant driver
ZebraProbe with Flushport
ARTHREX, INC.
AR-10500F
In Commercial Distribution

  • 00888867347731 ()
AR-10500F

  • Surgical drill guide, reusable
nGenuity with Printer
CRITICARE TECHNOLOGIES, INC.
nGenuity 8100EP
In Commercial Distribution

  • B4388100EPUS0 ()


  • General-purpose multi-parameter bedside monitor
nGenuity with CO2
CRITICARE TECHNOLOGIES, INC.
nGenuity 8100E1
In Commercial Distribution

  • B4388100E1US0 ()


  • General-purpose multi-parameter bedside monitor
FiberTak with SutureTape
ARTHREX, INC.
AR-3602
In Commercial Distribution

  • 00888867206946 ()
  • M150AR36021 ()
  • 10888867206943 ()
AR-3602

  • Tendon/ligament bone anchor, non-bioabsorbable
Introducer with handle
PRECISION SPINE, INC.
35-9012
In Commercial Distribution

  • 00815362023600 ()
35-9012

  • Orthopaedic surgical procedure kit, non-medicated, reusable
BabyMat with print
EXACT MEDICAL MANUFACTURING, INC.
E2150N
Not in Commercial Distribution

  • 00816953020558 ()
  • 00816953020541 ()
E2150N

  • Patient surgical drape, single-use
Adhesive with hydrogel
MC10, INC.
BRCA02
Not in Commercial Distribution

  • B493MC0009 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
with Vaginal Sensor
Laborie Medical Technologies Canada ULC
PRN09301
In Commercial Distribution

  • 10627825006283 ()


  • Perineometer
with Anal Sensor
Laborie Medical Technologies Canada ULC
PRN09300
In Commercial Distribution

  • 10627825006276 ()


  • Perineometer
Handle with quick-coupling
DIAMOND ORTHOPEDIC, LLC
DMD-311-430
In Commercial Distribution

  • B551DMD311430 ()
DMD-311-430

  • Surgical screwdriver, reusable
Tray with Lid
Stryker GmbH
XPL02400100
Not in Commercial Distribution

  • 07613252266433 ()
XPL02400100

  • Instrument tray, reusable
Grasper with Ratchet
STRYKER CORPORATION
0300034700
In Commercial Distribution

  • 07613327053456 ()

  • Outer Diameter: 3.4 Millimeter
0300-034-700

  • Ligament reconstruction instrument set, reusable
ARTHROSCOPY WITH POUCH-LF
MEDLINE INDUSTRIES, INC.
DYNJ902614J
In Commercial Distribution

  • 10198459211577 ()
DYNJ902614J

  • General surgical procedure kit, non-medicated, single-use
Suture with loop
RIVERPOINT MEDICAL, LLC
3910-900-076S
In Commercial Distribution

  • 00810020089653 ()


  • Polyolefin/fluoropolymer suture, multifilament
ACL WITH POUCH
Cardinal Health 200, LLC
SOP11A1SO7
In Commercial Distribution

  • 50197106292066 ()
  • 10197106292068 ()
SOP11A1SO7

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Bassinet with Cabinet
PEDICRAFT, INC.
18260
In Commercial Distribution

  • 00766923182604 ()
18260

  • Neonatal bed
Bassinet with Drawer
PEDICRAFT, INC.
18250
In Commercial Distribution

  • 00766923182505 ()
18250

  • Neonatal bed
Tube With Control
SYMMETRY SURGICAL INC.
70-4024
Not in Commercial Distribution

  • 00887482029961 ()
70-4024

  • Surgical/emergency suction cannula, non-illuminating, reusable
CANNULA WITH OUTLET
INTUITIVE SURGICAL, INC.
420254
In Commercial Distribution

  • 00886874111710 ()

  • Lumen/Inner Diameter: 8 Millimeter


  • Laparoscopic access cannula, reusable
ACL WITH POUCH
Cardinal Health 200, LLC
SOP11A1SO6
In Commercial Distribution

  • 50197106179220 ()
  • 10197106179222 ()
SOP11A1SO6

  • Orthopaedic surgical procedure kit, non-medicated, single-use
ACL WITH POUCH
Cardinal Health 200, LLC
SOP11A1SO5
In Commercial Distribution

  • 50197106116959 ()
  • 10197106116951 ()
SOP11A1SO5

  • Orthopaedic surgical procedure kit, non-medicated, single-use
ACL WITH POUCH
Cardinal Health 200, LLC
SOP11A1SO4
In Commercial Distribution

  • 50197106062911 ()
  • 10197106062913 ()
SOP11A1SO4

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Hydrogel with Alginate
SYSTAGENIX WOUND MANAGEMENT, LIMITED
MNG425U
In Commercial Distribution

  • 25051978010019 ()
  • 15051978010012 ()

  • Weight: 25 Gram
MNG425U

  • Wound hydrogel dressing, non-antimicrobial
Hydrogel with Alginate
SYSTAGENIX WOUND MANAGEMENT, LIMITED
MNG415U
In Commercial Distribution

  • 25051978010002 ()
  • 15051978010005 ()

  • Weight: 15 Gram
MNG415U

  • Wound hydrogel dressing, non-antimicrobial
SHOULDER WITH POUCH
Cardinal Health 200, LLC
SOPOCSPR10
In Commercial Distribution

  • 50195594833846 ()
  • 10195594833848 ()
SOPOCSPR10

  • Orthopaedic surgical procedure kit, non-medicated, single-use
LAMINECTOMY WITH BASIN
Cardinal Health 200, LLC
SNE69LMECD
In Commercial Distribution

  • 50885425766893 ()
  • 00885425766898 ()
SNE69LMECD

  • Neurosurgical procedure kit, non-medicated, single-use
CRANIOTOMY WITH BASIN
Cardinal Health 200, LLC
SNE69CRECD
In Commercial Distribution

  • 50885425766848 ()
  • 00885425766843 ()
SNE69CRECD

  • Craniotomy kit
SHOULDER WITH POUCH
Cardinal Health 200, LLC
SOPOCSPRA7
In Commercial Distribution

  • 50195594927293 ()
  • 10195594927295 ()
SOPOCSPRA7

  • Orthopaedic surgical procedure kit, non-medicated, single-use
ACL WITH POUCH
Cardinal Health 200, LLC
SOP11A1SO3
In Commercial Distribution

  • 50195594871312 ()
  • 10195594871314 ()
SOP11A1SO3

  • Orthopaedic surgical procedure kit, non-medicated, single-use
CANVAS WRIST WITH
DEROYAL INDUSTRIES, INC.
5066-48
In Commercial Distribution

  • 00749756107969 ()
5066-48

  • Hand/finger splint, single-use
CANVAS WRIST WITH
DEROYAL INDUSTRIES, INC.
5066-47
In Commercial Distribution

  • 00749756107952 ()
5066-47

  • Hand/finger splint, single-use
Vial With Solution
DEROYAL INDUSTRIES, INC.
31-VIAL19
In Commercial Distribution

  • 50749756372744 ()
  • 00749756372749 ()
31-VIAL19

  • Surgical suction system collection container, single-use
Rollator with Cupholder
VIVE HEALTH LLC
MOB1119GRY
In Commercial Distribution

  • 10810178880505 ()
  • 00810178880508 ()


  • Handgrip disability-assistive walker, non-powered, foldable
CYSTO WITH TUBING
MEDLINE INDUSTRIES, INC.
DYNJ84875A
In Commercial Distribution

  • 40198459174101 ()
  • 10198459174100 ()
DYNJ84875A

  • General surgical procedure kit, non-medicated, single-use
ARTHROSCOPY WITH POUCH-LF
MEDLINE INDUSTRIES, INC.
DYNJ902614K
In Commercial Distribution

  • 10198459312045 ()
DYNJ902614K

  • General surgical procedure kit, non-medicated, single-use
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