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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500ml Bottle of Bonding Liner for Acrylic Solder™
PARKELL, INC.
S815
In Commercial Distribution

  • 00810000529636 ()
S815

  • Denture reliner, hard
TUF-LINK 50 ml syringe Silicone Material incl. 10 mixing tips for TK-G Dispenser Gun.
Dentatus AB
TK-502
In Commercial Distribution

  • 07350081494827 ()
TK-502

  • Denture reliner, elastic, long-term
TUF-LINK 10 ml syringe Silicone Material incl. 3 mixing tips for TK-G-10 Dispenser Gun
Dentatus AB
TK-102
In Commercial Distribution

  • 07350081494810 ()
TK-102

  • Denture reliner, elastic, long-term
No Description
VOCO GmbH
1628
In Commercial Distribution

  • E22116281 ()
1628

  • Denture reliner, hard
Light-curing luting material for attachments and secondary denture parts
VOCO GmbH
1627
In Commercial Distribution

  • E22116271 ()
1627

  • Denture reliner, hard
Self-curing luting material for attachments and secondary denture parts
VOCO GmbH
1626
In Commercial Distribution

  • E22116261 ()
1626

  • Denture reliner, hard
Luting of prefabricated prosthetic teeth in denture basis, repair and extension of dental prosthesis
VOCO GmbH
6082
In Commercial Distribution

  • E22160821 ()
6082

  • Denture reliner, hard
Hard direct denture relining. The kit contains set + dispenser cartridge 80 g, adhesive bottle 10 ml and accessories.
VOCO GmbH
2218
In Commercial Distribution

  • E22122181 ()
2218

  • Denture reliner, hard
Hard direct denture relining.
VOCO GmbH
2217
In Commercial Distribution

  • E22122171 ()
2217

  • Denture reliner, hard
Hard direct denture relining.
VOCO GmbH
2216
In Commercial Distribution

  • E22122161 ()
2216

  • Denture reliner, hard
Hard direct denture relining. The kit contains set cartridge 80 g, adhesive bottle 10 ml and accessories.
VOCO GmbH
2215
In Commercial Distribution

  • E22122151 ()
2215

  • Denture reliner, hard
Mucopren Soft Basic Set + Applyfix 4 disp. gun
Kettenbach GmbH & Co. KG
28106
In Commercial Distribution

  • E217281061 ()
28106

  • Denture reliner, elastic, long-term
Mucopren Soft Basic Set
Kettenbach GmbH & Co. KG
28105
In Commercial Distribution

  • E217281051 ()
28105

  • Denture reliner, elastic, long-term
Mucopren Soft Normal pack
Kettenbach GmbH & Co. KG
15687
In Commercial Distribution

  • E217156871 ()
15687

  • Denture reliner, elastic, long-term
Mucopren silicone sealant Normal pack
Kettenbach GmbH & Co. KG
15686
In Commercial Distribution

  • E217156861 ()
15686

  • Denture reliner, elastic, long-term
Mucopren Adhesive
Kettenbach GmbH & Co. KG
14203
In Commercial Distribution

  • E217142031 ()
14203

  • Denture reliner, elastic, long-term
PROVISA RELINE HARD ADHES 10ML
BENCO DENTAL SUPPLY CO.
4634-399
In Commercial Distribution

  • D74446343990 ()


  • Denture reliner, hard
PROVISA RELINE HARD 1:1 REF
BENCO DENTAL SUPPLY CO.
4634-380
In Commercial Distribution

  • D74446343800 ()


  • Denture reliner, hard
PROVISA RELINE HRD 1:1 KIT
BENCO DENTAL SUPPLY CO.
4634-371
In Commercial Distribution

  • D74446343710 ()


  • Denture reliner, hard
PROVISA RELINE GLAZE REF BT
BENCO DENTAL SUPPLY CO.
4611-565
In Commercial Distribution

  • D74446115650 ()


  • Denture reliner, elastic, long-term
PROVISA CEM RELINE ADH REF BT
BENCO DENTAL SUPPLY CO.
4611-556
In Commercial Distribution

  • D74446115560 ()


  • Denture reliner, elastic, long-term
PROVISA CEM SFT RELINE CART RF
BENCO DENTAL SUPPLY CO.
4611-547
In Commercial Distribution

  • D74446115470 ()


  • Denture reliner, elastic, long-term
PROVISA CEM RELINE CART SFT KT
BENCO DENTAL SUPPLY CO.
4611-538
In Commercial Distribution

  • D74446115380 ()


  • Denture reliner, elastic, long-term
Schnidt Tonsil Forceps, 7 1/2", new old pattern
Avalign Technologies, Inc.
1-743075D
In Commercial Distribution

  • 00190776388652 ()


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
CLOWARD NEW TYPE BLADE RETR, 3'', 23mm NO LIP
SURGIX MEDICAL LLC
G2N52306
In Commercial Distribution


  • Length: 3 Inch
  • Tip Width 23 mm
G2N52306

  • Hand-held surgical retractor, reusable
CLOWARD NEW TYPE BLADE RETR, 3'', 18mm NO LIP
SURGIX MEDICAL LLC
G2N52304
In Commercial Distribution


  • Length: 3 Inch
  • Tip Width 18 mm
G2N52304

  • Hand-held surgical retractor, reusable
CLOWARD NEW TYPE BLADE RETR, 3'', 13mm NO LIP
SURGIX MEDICAL LLC
G2N52299
In Commercial Distribution


  • Length: 3 Inch
  • Tip Width 13 mm
G2N52299

  • Hand-held surgical retractor, reusable
YASARGIL MICRO SCIS (NEW) BAYO SERR 8'' CVD DN
SURGIX MEDICAL LLC
G2N1665
In Commercial Distribution

  • 00840343726447 ()

  • Length: 8 Inch
G2N1665

  • Neurosurgical scissors
B615 to D630 upgrade kits option with new ROTOR
GE Hualun Medical Systems Co., Ltd
H2401XF
In Commercial Distribution

  • 00840682145503 ()
H2401XF

  • Stationary gamma camera system
D615 NM GANTRY 3_8 WITH NEW ROTOR TOP - MEA
GE Hualun Medical Systems Co., Ltd
NM 615
In Commercial Distribution

  • 00840682139267 ()


  • Stationary gamma camera system
Abutment New Non Engaging for Angulated Channel JDEvolution Plus
J DENTAL CARE SRL
Abutment New Non Engaging for Angulated Channel JDEvolution Plus
In Commercial Distribution

  • 08056591022145 ()
EVA151C:

  • Dental implant system
new version of Mesa Labs pHoenix XL Dialysate Meter
MESA LABORATORIES, INC.
36-00001
In Commercial Distribution

  • M98536000010 ()
36-00300

  • Multi-parameter device tester
Syringe Irrigation Piston Flat Top with New Cath Tip
MCKESSON MEDICAL-SURGICAL INC.
911
In Commercial Distribution

  • 40612479201932 ()
  • 10612479201924 ()


  • ENFit oral/enteral syringe, single-use
Personal Use Kit OC-Auto, for Trinity Health New England
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-THNE
In Commercial Distribution

  • 00816917027128 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Yale New Haven Medical
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-YNHM
In Commercial Distribution

  • 00816917024547 ()


  • Faecal occult blood IVD, reagent
LinkStation MINI with Australia and New Zealand power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020457 ()
05000-002

  • Arthroplasty force sensor display unit
New Wider Grip In-Situ Sagittal Bender, 6.0 MM, Right
ALPHATEC SPINE, INC.
CI-11408-R-60
In Commercial Distribution

  • 00840180521366 ()


  • Manual orthopaedic bender, reusable
New Wider Grip In-Situ Sagittal Bender, 5.5 MM, Right
ALPHATEC SPINE, INC.
CI-11408-R-55
In Commercial Distribution

  • 00840180521359 ()


  • Manual orthopaedic bender, reusable
New Wider Grip In-Situ Sagittal Bender, 6.0 MM, Left
ALPHATEC SPINE, INC.
CI-11408-L-60
In Commercial Distribution

  • 00840180521342 ()


  • Manual orthopaedic bender, reusable
New Wider Grip In-Situ Sagittal Bender, 5.5 MM, Left
ALPHATEC SPINE, INC.
CI-11408-L-55
In Commercial Distribution

  • 00840180521335 ()


  • Manual orthopaedic bender, reusable
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