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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CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600785-001
In Commercial Distribution

  • J00716007850011 ()
1600785-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600692-001
In Commercial Distribution

  • J00716006920011 ()
1600692-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600691-001
In Commercial Distribution

  • J00716006910011 ()
1600691-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600690-001
In Commercial Distribution

  • J00716006900011 ()
1600690-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600284-001
In Commercial Distribution

  • J00716002840011 ()
1600284-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600200-001
In Commercial Distribution

  • J00716002000011 ()
1600200-001

  • Dental power tool system handpiece, remotely-driven
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211117 ()


  • Cancer antigen 19-9 (CA19-9) IVD, calibrator
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211148 ()


  • Cancer antigen 125 (CA125) IVD, calibrator
No Description
FUJIREBIO INC.
230664
Not in Commercial Distribution

  • 04987270230664 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 19-9 (CA19-9) IVD, calibrator
No Description
FUJIREBIO INC.
230640
In Commercial Distribution

  • 04987270230640 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
RAPIDPOINT® 350 Calcium Electrode, for use with RapidPoint® 350 analyzer
Siemens Healthcare Diagnostics Inc.
10376547
In Commercial Distribution

  • 00630414566771 ()
10376547

  • Calcium (Ca2+) electrode IVD
CA 125II - Atellica IM - Master Curve Material Kit 8 x 1 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
10995484
In Commercial Distribution

  • 00630414598116 ()
10995484

  • Cancer antigen 125 (CA125) IVD, control
FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version)
BIOFIRE DEFENSE, LLC
DFA2-ASY-0012
In Commercial Distribution

  • 00851458005266 ()
DFA2-ASY-0012

  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
A device which provides data communication and electrical isolation between the Video Processing Unit and the Clinician Programming System.
CORTIGENT, INC.
014103-002
Not in Commercial Distribution

014103

  • Retinal prosthesis system tester/clinical evaluator
No Description
Thoratec Corporation
107754OUS
Not in Commercial Distribution

  • 00813024013006 ()
107754OUS

  • Basic power supply, reusable
No Description
Roche Diagnostics GmbH
7762011190
In Commercial Distribution

  • 04015630946303 ()
7762011190

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
11776223161
In Commercial Distribution

  • 04015630945795 ()
11776223161

  • Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
3045838160
In Commercial Distribution

  • 04015630934379 ()
3045838160

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
5917972160
In Commercial Distribution

  • 04015630927906 ()
5917972160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
11776240322
In Commercial Distribution

  • 04015630918409 ()
11776240322

  • Cancer antigen 125 (CA125) IVD, calibrator
No Description
Roche Diagnostics GmbH
3045846122
In Commercial Distribution

  • 04015630918225 ()
3045846122

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
No Description
Drägerwerk AG & Co. KGaA
8418584
Not in Commercial Distribution

  • 04048675028000 ()


  • Nasal oxygen cannula, CPAP
Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
1890133
In Commercial Distribution

  • 04251204326175 ()
1890133

  • Microbial identification mass spectrometry system IVD
Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
1890132
In Commercial Distribution

  • 04251204326168 ()
1890132

  • Microbial identification mass spectrometry system IVD
For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873440
In Commercial Distribution

  • 00842768039416 ()
  • 00842768019845 ()
B4265-37

  • Buffered sample diluent IVD
Contains DIs: E235253A0; E235256A0; E235259A0; E235251A0; E235254A0; E235257A0;E23502530; E23502560; E23502230; E23502280
SHOFU DENTAL CORPORATION
0317B
In Commercial Distribution

  • E2350317B0 ()
0317B

  • Dental abrasive point, reusable
Contains DIs: E23504030; E23504040; E23504010; E23504020; E23502820; E23502850; E23502830; E23502860
SHOFU DENTAL CORPORATION
0308B
In Commercial Distribution

  • E2350308B0 ()
0308B

  • Dental abrasive point, reusable
Interface cable of 150" cable length with a round shape, 5-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684241
In Commercial Distribution

  • 50886333642415 ()
  • 00886333642410 ()

  • Cable length 150"
684241

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 12-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684230
In Commercial Distribution

  • 50886333642309 ()
  • 00886333642304 ()

  • cable length 150"
684230

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 4-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684188
In Commercial Distribution

  • 50886333641883 ()
  • 00886333641888 ()

  • cable length 150"
684188

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 8-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684183
In Commercial Distribution

  • 50886333641838 ()
  • 00886333641833 ()

  • cable length 150"
684183

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 5-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684147
In Commercial Distribution

  • 50886333641470 ()
  • 00886333641475 ()

  • cable length 150"
684147

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 6-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684139
In Commercial Distribution

  • 50886333641395 ()
  • 00886333641390 ()

  • cable length 150"
684139

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 5-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684138
In Commercial Distribution

  • 50886333641388 ()
  • 00886333641383 ()

  • cable length 150"
684138

  • Electrical-only medical device connection cable, reusable
Interface Cable to interface Transducer to Monitor. It has a 6-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684085
In Commercial Distribution

  • 50886333640855 ()
  • 00886333640850 ()

  • cable length 150"
684085

  • Electrical-only medical device connection cable, reusable
Interface Cable to interface Transducer to Monitor. It has a 8-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684082
In Commercial Distribution

  • 50886333640824 ()
  • 00886333640829 ()

  • cable length 150"
684082

  • Electrical-only medical device connection cable, reusable
Interface Cable to interface Transducer to Monitor. It has a 6-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684078
In Commercial Distribution

  • 50886333640787 ()
  • 00886333640782 ()

  • cable length 150"
684078

  • Electrical-only medical device connection cable, reusable
No Description
Epocal Inc
HH-1R09-CA-00
In Commercial Distribution

  • 00809708069124 ()
HH-1R09-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0R05-CA-00
In Commercial Distribution

  • 00809708064051 ()
HH-0R05-CA-00

  • Metabolic profile clinical chemistry analyser IVD
AS-895 Columbia Blood Agar (CA) is intended for the isolation, quantitation, and partial identification of a variety of microorganisms, including fastidious organisms from clinical specimens. CA is suitable for use in antibiotic differential disk examination and spot biochemical testing. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack.
ANAEROBE SYSTEMS
AS-895
In Commercial Distribution

  • 00810048902354 ()
  • 00810048901166 ()
AS-895

  • Enriched agar culture medium IVD
No Description
ALIMED, INC.
71326410
In Commercial Distribution

  • 00733657286632 ()
  • 00733657300529 ()
2970009212

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
71098510
In Commercial Distribution

  • 00733657286069 ()
  • 00733657300291 ()
2970008689

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
203210ML
In Commercial Distribution

  • 00733657285796 ()
  • 00733657300260 ()
2970000363

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
203210
In Commercial Distribution

  • 00733657285789 ()
  • 00733657300253 ()
2970000362

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
91-634
In Commercial Distribution

  • 00733657277432 ()
  • 00733657300031 ()
2970011683

  • Operating table torso positioner
Screwdriver SW3.5 cannulated
WITTENSTEIN intens GmbH
SCDR SW3.5 CA
Not in Commercial Distribution

  • 04260170140258 ()
60000406

  • Orthopaedic implant driver
The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
7 day - CA
In Commercial Distribution

  • 04250903201127 ()
2067634-177

  • Electrocardiographic ambulatory recorder
The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
48 hour - CA
In Commercial Distribution

  • 04250903201103 ()
2067634-176

  • Electrocardiographic ambulatory recorder
The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
24 hour - CA
In Commercial Distribution

  • 04250903201080 ()
2067634-175

  • Electrocardiographic ambulatory recorder
BiPAP Auto, Canada
Respironics, Inc.
BiPAP Auto, CA
In Commercial Distribution

  • 00606959031715 ()
761CA

  • Home BPAP unit
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