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 Class Implantable

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Tandem t:slim Mobile Application, iOS version 2.9
Tandem Diabetes Care, Inc.
1014707
In Commercial Distribution

  • 00389152470740 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
SFTWR CSS7200 GRDN MBL IOS V 4.1.0
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000381103 ()


  • Patient health record information system application software
SFTWR MMT-6114 CL CONN CLIN IOS 2.1.1
MEDTRONIC MINIMED, INC.
MMT-6114
In Commercial Distribution

  • 00763000480653 ()


  • Patient health record information system application software
On1 IOS Healing Cap 4 mm WP
Nobel Biocare AB
38739
In Commercial Distribution

  • 07332747113747 ()

  • Height: 4.000 Millimeter
38739

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 5 mm WP
Nobel Biocare AB
38738
In Commercial Distribution

  • 07332747113730 ()

  • Height: 5.000 Millimeter
38738

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm RP
Nobel Biocare AB
38737
In Commercial Distribution

  • 07332747113723 ()

  • Height: 4.500 Millimeter
38737

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm RP
Nobel Biocare AB
38736
In Commercial Distribution

  • 07332747113716 ()

  • Height: 6.000 Millimeter
38736

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm NP
Nobel Biocare AB
38735
In Commercial Distribution

  • 07332747113709 ()

  • Height: 4.500 Millimeter
38735

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm NP
Nobel Biocare AB
38734
In Commercial Distribution

  • 07332747113693 ()

  • Height: 6.000 Millimeter
38734

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4 mm WP
Nobel Biocare AB
38739
In Commercial Distribution

  • 07332747191875 ()

  • Height: 4.000 Millimeter
38739

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 5 mm WP
Nobel Biocare AB
38738
In Commercial Distribution

  • 07332747191868 ()

  • Height: 5.000 Millimeter
38738

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm RP
Nobel Biocare AB
38737
In Commercial Distribution

  • 07332747191851 ()

  • Height: 4.500 Millimeter
38737

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm RP
Nobel Biocare AB
38736
In Commercial Distribution

  • 07332747191844 ()

  • Height: 6.000 Millimeter
38736

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm NP
Nobel Biocare AB
38735
In Commercial Distribution

  • 07332747191837 ()

  • Height: 4.500 Millimeter
38735

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm NP
Nobel Biocare AB
38734
In Commercial Distribution

  • 07332747191820 ()

  • Height: 6.000 Millimeter
38734

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC WP
Nobel Biocare AB
38191
Not in Commercial Distribution

  • 07332747175967 ()
38191

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC RP
Nobel Biocare AB
38190
Not in Commercial Distribution

  • 07332747175950 ()
38190

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC NP
Nobel Biocare AB
38189
Not in Commercial Distribution

  • 07332747175943 ()
38189

  • Dental implant suprastructure, temporary, preformed, single-use
SFTWR MMT-8100 IOS WATSON APP V2.1 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution

  • 00763000086619 ()


  • Self-care monitoring/reporting software
SFTWR CSS7200 GRDN MBL APP IOS V3.2.3
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000186333 ()


  • Patient health record information system application software
SFTWR MMT-8100 IOS WATSON APP V3.0 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution

  • 00763000168643 ()


  • Self-care monitoring/reporting software
NP IOS Model Implant Replica CC 3.0
Nobel Biocare AB
38188
Not in Commercial Distribution

  • 07332747175936 ()

  • Outer Diameter: 3.000 Millimeter
38188

  • Dental implant suprastructure, temporary, preformed, single-use
Lumify Diagnostic Ultrasound System iOS Release 5.1
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838124141 ()


  • General-purpose ultrasound imaging system
SFTWR MMT-6104 MM MBL CLIN IOS 1.0.0
MEDTRONIC MINIMED, INC.
MMT-6104
Not in Commercial Distribution

  • 00763000480677 ()


  • Self-care monitoring/reporting software
SW MMT-8060 INPEN 2.0 IOS APP US
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000974589 ()


  • Empty self-injector, mechanical
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
SFTWR MMT-8400 1.1 CGM MODULE IOS US
MEDTRONIC MINIMED, INC.
MMT-8400
In Commercial Distribution

  • 00763000721350 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Aadva™ IOS 100: IOS cart, IOS Handpiece (via USB connection), CPU (onboard computer), G.U.I. touchscreen, holder inserts bags of 10, plug, IFUs (includes: Quick Start Guide & Owners manual).
Gc America Inc.
940502
In Commercial Distribution

  • J0229405021 ()
940502

  • Dental milling system, CAD/CAM, laboratory
TC-FFL Interlayer Foils
INSPIRATION HEALTHCARE LIMITED
TC-FFL
In Commercial Distribution

  • 05060206921788 ()


  • External circulating-fluid core temperature regulation system pad, reusable
Repose Trolley Companion Cover
Frontier Therapeutics Inc
6990012
In Commercial Distribution

  • 05056279301022 ()


  • Air-filled bed mattress overlay
Repose Companion Cover
Frontier Therapeutics Inc
6990002
In Commercial Distribution

  • 05056279301008 ()


  • Waterproof bed mattress cover, reusable
Repose Trolley Mattress Cover
Frontier Therapeutics Inc
6980001
In Commercial Distribution

  • 05056279300988 ()


  • Waterproof bed mattress cover, reusable
Repose Contur Cover
Frontier Therapeutics Inc
6310000
In Commercial Distribution

  • 05056279300940 ()


  • Air-filled chair cushion
Repose Blue Cushion over EU 45cm
Frontier Therapeutics Inc
6211101
In Commercial Distribution

  • 05056279300889 ()


  • Waterproof bed mattress cover, reusable
No Description
ATOM MEDICAL CORPORATION
60321
In Commercial Distribution

  • 04942962603218 ()
  • 84942962603214 ()
60321

  • Basic bed sheet, single-use
No Description
ATOM MEDICAL CORPORATION
26122
In Commercial Distribution

  • 04942962261227 ()
  • 84942962261223 ()
  • 14942962261224 ()
26122

  • Basic bed sheet, single-use
EXCEL COMPLY PAD 7.5OZ PAD W/ NONWVN TRI-COMPONENT
STANDARD TEXTILE CO., INC.
61061110
In Commercial Distribution

  • 00634916001976 ()
  • 10634916001973 ()
61061110

  • Basic bed sheet, reusable
EXCEL COMPLY QUILTED PAD 30X36 10.5OZ NONWVN SEWN VINTEX BARRIER
STANDARD TEXTILE CO., INC.
61059100
In Commercial Distribution

  • 00634916001969 ()
  • 10634916001966 ()
61059100

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED BRDS 33X36 W/8 OZ NONWOVEN VINTEX
STANDARD TEXTILE CO., INC.
59752100
Not in Commercial Distribution

  • 00634916001952 ()
  • 10634916001959 ()
59752100

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED W/TUCK-INS 33X36 SPECTRA W/8OZ NONWVN VIN
STANDARD TEXTILE CO., INC.
59750101
In Commercial Distribution

  • 00634916001945 ()
  • 10634916001942 ()
59750101

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED SPECTRA 33X36 W/8OZ NONWVN VINTEX BARRIER SEWN
STANDARD TEXTILE CO., INC.
59750100
In Commercial Distribution

  • 00634916001938 ()
  • 10634916001935 ()
59750100

  • Absorbent underpad, non-antimicrobial, reusable
EXCEL PLUS COMPLY QUILTED PAD KAUM 30X36 RM (98 6465) USE: 61064100
STANDARD TEXTILE CO., INC.
61064P41
Not in Commercial Distribution

  • 00634916014396 ()
  • 10634916014393 ()
61064P41

  • Absorbent underpad, non-antimicrobial, reusable
5" Version
Trinity Guardion, Inc.
Universal Stretcher UNVST5-0000
In Commercial Distribution

  • 00850045714406 ()


  • Waterproof bed mattress cover, reusable
No Description
Trinity Guardion, Inc.
Giraffe Standard GIRSTD-0000
In Commercial Distribution

  • 00850045714369 ()
  • 00850045714376 ()
  • 00850045714383 ()
  • 00850045714390 ()


  • Waterproof bed mattress cover, reusable
No Description
Trinity Guardion, Inc.
Universal Pediatric 26191X-0000
In Commercial Distribution

  • 00850045714321 ()
  • 00850045714338 ()
  • 00850045714345 ()
  • 00850045714352 ()


  • Waterproof bed mattress cover, reusable
Silver Coverlet with Zipper
KREG MEDICAL INC.
ASM100118
In Commercial Distribution

  • 00850520008211 ()


  • Waterproof bed mattress cover, reusable
  • Antimicrobial bed mattress cover
Deep Purple Coverlet with Zipper
KREG MEDICAL INC.
ASM100117
In Commercial Distribution

  • 00850520008204 ()


  • Waterproof bed mattress cover, reusable
  • Antimicrobial bed mattress cover
Stretcher Sheet, White, SMS 108x51
ICP MEDICAL, LLC
1
In Commercial Distribution

  • 00688162000481 ()

  • Length: 96 Inch
  • Width: 37 Inch
ICP-9003GUR

  • Waterproof bed mattress cover, reusable
Stretcher Sheet, White, SMS 96x37
ICP MEDICAL, LLC
2
In Commercial Distribution

  • 10688162000464 ()
  • 00688162000467 ()
  • 20688162000461 ()

  • Length: 96 Inch
  • Width: 37 Inch
ICP-9001GUR

  • Waterproof bed mattress cover, reusable
DERMATHERAPY UNDERPAD; PAD 36IN-EA
JOERNS HEALTHCARE, LLC
DT-PAD-3436-EA
In Commercial Distribution

  • 20857268006947 ()
  • 00857268006943 ()


  • Antimicrobial bed linen set
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