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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X Factor Exam Grade Nitrile Gloves Size XXL
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-XXL-100
In Commercial Distribution

  • 00850044884049 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size XL
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-XL-100
In Commercial Distribution

  • 00850044884032 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size L
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-L-100
In Commercial Distribution

  • 00850044884025 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size M
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-M-100
In Commercial Distribution

  • 00850044884018 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size S
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-S-100
In Commercial Distribution

  • 00850044884001 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
SCREW, PDLLA
KLS-Martin L.P.
52-022-25-04
In Commercial Distribution

  • 10888118101089 ()
  • 00888118101082 ()

  • 2.1 X 5 MM


  • Craniofacial bone screw, bioabsorbable
No Description
Siemens Healthcare GmbH
10281299
In Commercial Distribution

  • 04056869010120 ()


  • Diagnostic x-ray digital imaging system workstation
No Description
Siemens Healthcare GmbH
10502522
In Commercial Distribution

  • 04056869010113 ()


  • Diagnostic x-ray digital imaging system workstation
The FCR CARBON X (CR-IR 357) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 357
In Commercial Distribution

  • 04547410265903 ()


  • Computed radiography digital imaging scanner
No Description
ASAHI INTECC CO., LTD.
AIN-CKX-10-200-R
In Commercial Distribution


  • Outer Diameter: 0.01 Inch
  • Length: 200 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
MinerOss X Syringe 250µ-1000µ (0.5cc)
ACE SURGICAL SUPPLY CO., INC.
BH0053
In Commercial Distribution

  • 00614950028047 ()
BH0053

  • Dental bone matrix implant, animal-derived
MinerOss X Syringe 250µ-1000µ (0.25cc)
ACE SURGICAL SUPPLY CO., INC.
BH0052
In Commercial Distribution

  • 00614950028030 ()
BH0052

  • Dental bone matrix implant, animal-derived
MinerOss X Cancellous LP 1000µm-2000µm (2.0g/6.8cc)
ACE SURGICAL SUPPLY CO., INC.
BH0047
In Commercial Distribution

  • 00614950028023 ()
BH0047

  • Dental bone matrix implant, animal-derived
MinerOss X Cancellous LP 1000µm-2000µm (1.0g/3.4cc)
ACE SURGICAL SUPPLY CO., INC.
BH0046
In Commercial Distribution

  • 00614950028016 ()
BH0046

  • Dental bone matrix implant, animal-derived
MinerOss X Cancellous LP 1000µm-2000µm (.05g/1.7cc)
ACE SURGICAL SUPPLY CO., INC.
BH0045
In Commercial Distribution

  • 00614950028009 ()
BH0045

  • Dental bone matrix implant, animal-derived
MinerOss X Cancellous LP 1000µm-2000µm (0.25g/0.9cc)
ACE SURGICAL SUPPLY CO., INC.
BH0044
In Commercial Distribution

  • 00614950027996 ()
BH0044

  • Dental bone matrix implant, animal-derived
MinerOss X Cancellous 250µ-1000µ (2.0g/4.7cc)
ACE SURGICAL SUPPLY CO., INC.
BH0039
In Commercial Distribution

  • 00614950027989 ()
BH0039

  • Dental bone matrix implant, animal-derived
MinerOss X Cancellous 250µ-1000µ (1.0g/2.4cc)
ACE SURGICAL SUPPLY CO., INC.
BH0038
In Commercial Distribution

  • 00614950027972 ()
BH0038

  • Dental bone matrix implant, animal-derived
MinerOss X Cancellous 250µ-1000µ (.5g/1.2cc)
ACE SURGICAL SUPPLY CO., INC.
BH0037
In Commercial Distribution

  • 00614950027965 ()
BH0037

  • Dental bone matrix implant, animal-derived
MinerOss X Cancellous 250µ-1000µ (.25g/.6cc)
ACE SURGICAL SUPPLY CO., INC.
BH0036
In Commercial Distribution

  • 00614950027958 ()
BH0036

  • Dental bone matrix implant, animal-derived
MinerOss X Plug Tapered 9X15MM 5/BOX
ACE SURGICAL SUPPLY CO., INC.
BH0035
In Commercial Distribution

  • 10614950027948 ()
  • 00614950027941 ()
BH0035

  • Dental bone matrix implant, animal-derived
MinerOss X Plug Straight 10X20MM 5/BOX
ACE SURGICAL SUPPLY CO., INC.
BH0034
In Commercial Distribution

  • 10614950027931 ()
  • 00614950027934 ()
BH0034

  • Dental bone matrix implant, animal-derived
Ultrasound Doppler Device with CO2 measuring module
Compumedics Germany GmbH
MDX R12 CO2
In Commercial Distribution

  • 04260493310031 ()
7882

  • Noninvasive vascular ultrasound system, line-powered
  • Invasive vascular ultrasound system
Ultrasound Doppler Device
Compumedics Germany GmbH
MDX R12
In Commercial Distribution

  • 04260493310017 ()
7880

  • Invasive vascular ultrasound system
  • Noninvasive vascular ultrasound system, line-powered
“X” Osteotome, 7mm
SYMMETRY MEDICAL INC.
10-008-400
In Commercial Distribution

  • 00847538006360 ()
2709-01-010

  • Orthopaedic osteotome
“X” Osteotome, 7mm
SYMMETRY MEDICAL INC.
10-008-000
In Commercial Distribution

  • 00847538001235 ()
00-9986-010-17;00-9986-010-17

  • Orthopaedic osteotome
DEVICE IDENTIFIER, MAIN ASSY, X SERIES ADVANCED MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, NO VOICE, ETCO2, NIBP, BVM, IBP, NIBP, SPO2, SPCO, SPMET (RAINBOW/MASIMO), CPR EXPANSION PACK, MOBILE STREAMING, GERMAN
Zoll Medical Corporation
630-2241712-08
In Commercial Distribution

  • 00847946049959 ()

  • 8.9" x 10.4" x 8.75"


  • Physiologic-monitoring defibrillation system
STENT SFR4-6-40-10 V01 US
Micro Therapeutics, Inc.
SFR4-6-40-10
In Commercial Distribution

  • 00847536034730 ()


  • Thrombectomy wire-net
STENT SFR4-6-20-10 V01 US
Micro Therapeutics, Inc.
SFR4-6-20-10
In Commercial Distribution

  • 00847536034716 ()


  • Thrombectomy wire-net
Single-lead ECG monitor intended to capture, store, transmit and display electrocardiogram (ECG) information for long term monitoring and evaluation.
FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED
Frontier X Plus
In Commercial Distribution

  • 08908013617128 ()


  • Electrocardiographic long-term ambulatory recording analyser
  • Telemetric electrocardiographic ambulatory recorder
  • Electrocardiograph, home-use
Stainless Steel. Used to replicate the position of the implant in a working implant cast. Made from Stainless steel.
STERNGOLD DENTAL LLC
904547
In Commercial Distribution

  • 00841549117374 ()


  • Dental implant analog
GRYPHON FLEX X DISPOSABLE INSTRUMENT KIT
Medos International Sàrl
271079
In Commercial Distribution

  • 10886705033294 ()
271079

  • Orthopaedic surgical procedure kit, non-medicated, single-use
GRYPHON FLEX X DRILL REUSABLE
Medos International Sàrl
271076
In Commercial Distribution

  • 10886705033263 ()
271076

  • Fluted surgical drill bit, single-use
No Description
Osstem Implant Co., Ltd.
SGCB30S
In Commercial Distribution

  • 08800121767859 ()


  • Dental implantation depth/angle gauge, reusable
PLASMABLADE X PS200-040 4.0 PINK
MEDTRONIC NAVIGATION, INC.
PS200-040
In Commercial Distribution

  • 00643169936638 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Over the counter red/IR device for the treatment of wrinkles.
Omm Imports Inc.
G2-PX
In Commercial Distribution

  • 00850001456548 ()


  • Cosmetic red-light phototherapy system, home-use
SCREW, PDLLA
KLS-Martin L.P.
52-024-27-04
In Commercial Distribution

  • 10888118000085 ()
  • 00888118000088 ()

  • 2.4 X 7 MM


  • Craniofacial bone screw, bioabsorbable
SCREW, PDLLA
KLS-Martin L.P.
52-024-25-04
In Commercial Distribution

  • 10888118000078 ()
  • 00888118000071 ()

  • 2.4 X 5 MM


  • Craniofacial bone screw, bioabsorbable
SCREW, PDLLA
KLS-Martin L.P.
52-021-29-04
In Commercial Distribution

  • 10888118000061 ()
  • 00888118000064 ()

  • 2.1 X 9 MM


  • Craniofacial bone screw, bioabsorbable
SCREW, PDLLA
KLS-Martin L.P.
52-021-27-04
In Commercial Distribution

  • 10888118000054 ()
  • 00888118000057 ()

  • 2.1 X 7 MM


  • Craniofacial bone screw, bioabsorbable
SCREW, PDLLA
KLS-Martin L.P.
52-021-24-04
In Commercial Distribution

  • 10888118000047 ()
  • 00888118000040 ()

  • 2.1 X 4 MM


  • Craniofacial bone screw, bioabsorbable
SCREW, PDLLA
KLS-Martin L.P.
52-020-57-04
In Commercial Distribution

  • 10888118000030 ()
  • 00888118000033 ()

  • 2.1 X 7 MM


  • Craniofacial bone screw, bioabsorbable
SCREW, PDLLA
KLS-Martin L.P.
52-020-55-04
In Commercial Distribution

  • 10888118000023 ()
  • 00888118000026 ()

  • 2.1 X 5 MM


  • Craniofacial bone screw, bioabsorbable
SCREW, PDLLA
KLS-Martin L.P.
52-020-54-04
In Commercial Distribution

  • 10888118000016 ()
  • 00888118000019 ()

  • 2.1 X 4 MM


  • Craniofacial bone screw, bioabsorbable
SCREW, PDLLA
KLS-Martin L.P.
52-022-24-04
In Commercial Distribution

  • 10888118101072 ()
  • 00888118101075 ()

  • 2.1 X 4 MM


  • Craniofacial bone screw, bioabsorbable
MinerOss X Syringe Particle Size 0.25mm - 1.0mm 0.5 cc
ACE SURGICAL SUPPLY CO., INC.
BH0033
Not in Commercial Distribution

  • 00614950009084 ()

  • 0.5 cc
BH0033

  • Dental bone matrix implant, animal-derived
MinerOss X Syringe Particle Size 0.25mm - 1.0mm 0.25cc
ACE SURGICAL SUPPLY CO., INC.
BH0032
Not in Commercial Distribution

  • 00614950009077 ()

  • 0.25 cc
BH0032

  • Dental bone matrix implant, animal-derived
MinerOss X COLLAGEN SIZE 6X7X8MM
ACE SURGICAL SUPPLY CO., INC.
MINX-Collagen-SM
In Commercial Distribution

  • 00614950008896 ()

  • 6mm x 7mm x 8mm
BH0041NS

  • Dental bone matrix implant, animal-derived
MinerOss® X CANCELLOUS PARTICLE SIZE 250-1000µ 0.25G/.5CC
ACE SURGICAL SUPPLY CO., INC.
MINX-CAN0.25GR
In Commercial Distribution

  • 00614950008889 ()

  • Weight: 0.25 Gram
BH0021NS

  • Dental bone matrix implant, animal-derived
MinerOss®X CORTICAL PARTICLE
ACE SURGICAL SUPPLY CO., INC.
BH0014
In Commercial Distribution

  • 00614950007974 ()
BH0014

  • Dental bone matrix implant, animal-derived
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