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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IDODENTINE DISC DARK PINK V2 98,5/25mm
UNION DENTAL SA
DISC DARK PINK V2 (#1L) 98,5/25mm
In Commercial Distribution

  • 08435288443614 ()
4225/#1L (V2)

  • Temporary dental crown/bridge
Smart Hand Piece (SHP)_800um Fiber Assy v2
LITECURE LLC
PRD-000758-010-00-L
In Commercial Distribution

  • 00854103007134 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Ambu aView 2 Advance (gen2) US CIB V2
Ambu A/S
405011000US2
In Commercial Distribution

  • 05707480156757 ()
405011000US2

  • Endoscopic video image display unit
Dental LT Comfort (V1.1) used with Cartridge V2
FORMLABS OHIO INC.
FLDLCO11
In Commercial Distribution

  • 00850061175106 ()


  • Dental appliance fabrication material, resin
Premium Teeth Resin (HT A3) for cartridge v2
FORMLABS OHIO INC.
FLPTA301
In Commercial Distribution

  • 00850061175038 ()


  • Resin artificial teeth
Premium Teeth Resin (HT B1) for cartridge v2
FORMLABS OHIO INC.
FLPTB101
In Commercial Distribution

  • 00850061175021 ()


  • Resin artificial teeth
Premium Teeth Resin (HT A2) for cartridge v2
FORMLABS OHIO INC.
FLPTA201
In Commercial Distribution

  • 00850061175014 ()


  • Resin artificial teeth
Premium Teeth Resin (HT Bleach) for cartridge v2
FORMLABS OHIO INC.
FLPTBL01
In Commercial Distribution

  • 00850061175007 ()


  • Resin artificial teeth
ORT200 50/60Hz Covered Table Assy V2, 114148-600
IMRIS Imaging, Inc.
ORT200
In Commercial Distribution

  • 00857534006479 ()


  • Basic diagnostic x-ray system table, powered
ORT200 50/60Hz Covered Table Assy V2, 114148-000
IMRIS Imaging, Inc.
ORT200
In Commercial Distribution

  • 00857534006349 ()


  • Basic diagnostic x-ray system table, powered
DISP V2 XS FACE PC/HG/MASK ADP
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750004911 ()
201668

  • Pulmonary function valve
DISP V2 SM FACE PC/HG/MASK ADP
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750004904 ()
201667

  • Pulmonary function valve
77 V2 ASSY EX SM 22ID NO HG
HANS RUDOLPH, INC.
7700
Not in Commercial Distribution

  • 00874750003730 ()
113588

  • CPAP/BPAP face mask, reusable
77 V2 ASSY EX SM 22OD NO HG
HANS RUDOLPH, INC.
7700
Not in Commercial Distribution

  • 00874750003686 ()
113583

  • CPAP/BPAP face mask, reusable
76 V2 ASSY EX SM 22OD NO HG
HANS RUDOLPH, INC.
7600
In Commercial Distribution

  • 00874750003587 ()
113573

  • CPAP/BPAP face mask, reusable
65 V2 EX SMALL 22ID STR W/HG
HANS RUDOLPH, INC.
6500
In Commercial Distribution

  • 00874750003433 ()
113543

  • CPAP/BPAP face mask, single-use
65 V2 EX SMALL 22OD STR W/HG
HANS RUDOLPH, INC.
6500
In Commercial Distribution

  • 00874750003389 ()
113538

  • CPAP/BPAP face mask, single-use
65 V2 EX SMALL 22ID ELB W/HG
HANS RUDOLPH, INC.
6500
In Commercial Distribution

  • 00874750003334 ()
113533

  • CPAP/BPAP face mask, single-use
65 V2 EX SMALL 22OD ELB W/HG
HANS RUDOLPH, INC.
6500
In Commercial Distribution

  • 00874750003280 ()
113528

  • CPAP/BPAP face mask, single-use
75 V2 EX SMALL 22ID STR W/HG
HANS RUDOLPH, INC.
7500
In Commercial Distribution

  • 00874750003235 ()
113523

  • CPAP/BPAP face mask, reusable
75 V2 EX SMALL 22OD ELB W/HG
HANS RUDOLPH, INC.
7500
In Commercial Distribution

  • 00874750003082 ()
113508

  • CPAP/BPAP face mask, reusable
6450 V2 SM MASK SPU HG/FLEX MA
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750005529 ()
113822

  • Pulmonary function valve
6450 V2 MD MASK SPU HG/FLEX MA
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750005512 ()
113821

  • Pulmonary function valve
6450 V2 LG MASK SPU HG/FLEX MA
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750005505 ()
113820

  • Pulmonary function valve
7450 V2 PET MASK W/HG/FLEX MA
HANS RUDOLPH, INC.
7450
In Commercial Distribution

  • 00874750005499 ()
113816

  • Pulmonary function valve
7450 V2 X-SM MASK W/HG/FLEX MA
HANS RUDOLPH, INC.
7450
In Commercial Distribution

  • 00874750005482 ()
113815

  • Pulmonary function valve
7450 V2 SM MASK W/HG/FLEX MA
HANS RUDOLPH, INC.
7450
In Commercial Distribution

  • 00874750005475 ()
113814

  • Pulmonary function valve
7450 V2 MED MASK W/HG/FLEX MA
HANS RUDOLPH, INC.
7450
In Commercial Distribution

  • 00874750005468 ()
113813

  • Pulmonary function valve
7450 V2 LG MASK W/HG/FLEX MA
HANS RUDOLPH, INC.
7450
In Commercial Distribution

  • 00874750005451 ()
113812

  • Pulmonary function valve
76 V2 ASSY LARGE 22OD W/SM HG
HANS RUDOLPH, INC.
7600
In Commercial Distribution

  • 00874750005239 ()
113809

  • CPAP/BPAP face mask, reusable
76 V2 ASSY LARGE 22OD W/MED HG
HANS RUDOLPH, INC.
7600
In Commercial Distribution

  • 00874750005222 ()
113808

  • CPAP/BPAP face mask, reusable
DISP V2 MD FACE PC/HG/MASK ADP
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750004898 ()
201666

  • Pulmonary function valve
DISP V2 LG FACE PC/HG/MASK ADP
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750004881 ()
201665

  • Pulmonary function valve
75 V2 EX SM 22ID ELBOW NO HG
HANS RUDOLPH, INC.
7500
In Commercial Distribution

  • 00874750003846 ()
113598

  • CPAP/BPAP face mask, reusable
75 V2 EX SM 22OD ELBOW NO HG
HANS RUDOLPH, INC.
7500
In Commercial Distribution

  • 00874750003792 ()
113593

  • CPAP/BPAP face mask, reusable
76 V2 ASSY EX SM 22ID NO HG
HANS RUDOLPH, INC.
7600
In Commercial Distribution

  • 00874750003631 ()
113578

  • CPAP/BPAP face mask, reusable
75 V2 EX SMALL 22OD STR W/HG
HANS RUDOLPH, INC.
7500
In Commercial Distribution

  • 00874750003181 ()
113518

  • CPAP/BPAP face mask, reusable
75 V2 EX SMALL 22ID ELB W/HG
HANS RUDOLPH, INC.
7500
In Commercial Distribution

  • 00874750003136 ()
113513

  • CPAP/BPAP face mask, reusable
V2 facemask- Deesse Pro Express Branded (Harpar Grace)
I-SMART DEVELOPMENTS LIMITED
TN19G
In Commercial Distribution

  • 05060534510395 ()
111B

  • Cosmetic red-light phototherapy system, home-use
LiDCOrapid v2 Assembly with LiDCO CNAP Assembly, comprising:
LIDCO LIMITED
Li10884
In Commercial Distribution

  • 05060110521968 ()
Li10884

  • General-purpose multi-parameter bedside monitor
Leadwire Shielded AMC Din to Snap, 29" V2
Advantage Medical Electronics, LLC
LW-2090S29V2
In Commercial Distribution

  • 00849593030649 ()


  • Electrocardiographic lead set, reusable
MPH57992 NUP98 Distal in FITC Spectrum V2 (ASR)
CYTOCELL LIMITED
MPH57992
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
MLL Distal v2 in Texas Red Spectrum (ASR)
CYTOCELL LIMITED
MPD33451
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
EMG v22 to Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630300
In Commercial Distribution

  • 00382830045070 ()


  • Electromyograph
UNVCA5SHF @VERSAPORT V2 UNV 5 MM SHRT FI
MEDLINE INDUSTRIES, INC.
UNVCA5SHFR
In Commercial Distribution

  • 20888277416199 ()
  • 10888277416192 ()
UNVCA5SHFR

  • Laparoscopic access cannula, reprocessed
UNVCA5LGF @VERSAPORT V2 UNV 5 MM LONG FI
MEDLINE INDUSTRIES, INC.
UNVCA5LGFR
In Commercial Distribution

  • 20888277416182 ()
  • 10888277416185 ()
UNVCA5LGFR

  • Laparoscopic access cannula, reprocessed
ProEX Telehealth Hub System FSC2 - NTSC - CLINICIAN v2
VISIONFLEX PTY. LTD.
VFPROEX24.02
In Commercial Distribution

  • 09352527000584 ()
  • 09352527000713 ()


  • Patient monitoring system module, data memory
ProEX Telehealth Hub System FSC2 PAL - CLINICIAN v2
VISIONFLEX PTY. LTD.
VFPROEX22.02
In Commercial Distribution

  • 09352527000560 ()
  • 09352527000690 ()


  • Patient monitoring system module, data memory
MOSS VRS in:situ Ti Reduction Head HP V2
Biedermann Motech GmbH & Co. KG
108-017-0006
In Commercial Distribution

  • 04255772609166 ()
108-017-0006

  • Spinal bone screw head/rod adaptor
TROCAR VERSAPORT V2 RT OBTURATOR WITH 5MM SEAL
STERILMED, INC.
AUT179101
Not in Commercial Distribution

  • 10888551013222 ()
AUT179101

  • Laparoscopic access cannula, reprocessed
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