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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Basket Liposuction Cannula 4mm x 26cm Black Handle
Ebner Medical, LLC
BB0034026
In Commercial Distribution

  • 00840217907125 ()

  • Length: 26 Centimeter
  • Width: 4 Millimeter
BB0034026

  • Surgical/emergency suction cannula, non-illuminating, reusable
Double Mercedes Liposuction Cannula 2mm x 15cm Black Handle
Ebner Medical, LLC
CC1012015
In Commercial Distribution

  • 00840217907118 ()

  • Length: 15 Centimeter
  • Width: 2 Millimeter
CC1012015

  • Surgical/emergency suction cannula, non-illuminating, reusable
VOCOM VOCAL CORD MDEIAL INSTR STER CASE
Gyrus ACMI, LLC
134007
In Commercial Distribution

  • 00821925015425 ()


  • ENT elevator
GUILFORD ADHESION PICK 45 DEGREE TIP ANGLE 1 MM TIP ANGLE STAINLESS STEEL
Gyrus ACMI, LLC
130260
In Commercial Distribution

  • 00821925012424 ()


  • Middle ear pick
VOCOM VOCAL CORD MEDIALIZATION TRIAL 6MM DISPLACEMENT STAINLESS STEEL
Gyrus ACMI, LLC
134003
In Commercial Distribution

  • 00821925012394 ()


  • Nasal depth gauge, reusable
WEBSTER NEEDLE HOLDER 6"
Gyrus ACMI, LLC
231032
In Commercial Distribution

  • 00821925019522 ()


  • Surgical irrigation/aspiration handpiece, reusable
No Description
FGX INTERNATIONAL INC.
VH1158865.VER
In Commercial Distribution

  • 00193033378915 ()


  • Prescription spectacles
No Description
GYNEX CORPORATION
CO4100-LED
In Commercial Distribution

  • GYNXCO4100LED0 ()


  • Colposcope
No Description
GYNEX CORPORATION
CO3100-LED
In Commercial Distribution

  • GYNXCO3100LED0 ()


  • Colposcope
No Description
GYNEX CORPORATION
CO1100-LED
In Commercial Distribution

  • GYNXCO1100LED0 ()


  • Colposcope
No Description
Poskom Co., Ltd.
PXP-15HF
In Commercial Distribution

  • 08800040900061 ()


  • Diagnostic x-ray system generator, portable
No Description
Poskom Co., Ltd.
Rextar X
In Commercial Distribution

  • 08800040900047 ()


  • Diagnostic x-ray system generator, portable
No Description
Poskom Co., Ltd.
PXP-40HF
In Commercial Distribution

  • 08800040900030 ()


  • Diagnostic x-ray system generator, portable
No Description
Poskom Co., Ltd.
PXP-20HF
In Commercial Distribution

  • 08800040900023 ()


  • Diagnostic x-ray system generator, portable
No Description
Poskom Co., Ltd.
PXM-40BT
In Commercial Distribution

  • 08800040900016 ()


  • Diagnostic x-ray system generator, portable
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031820320 ()


  • Dental casting non-noble alloy
Inami Hook Micro Trabeculotomy, ab interno, TANITO, Shoji Edition, Right
Diamatrix
M-2220R
In Commercial Distribution

  • 00810163790379 ()
M-2220R

  • Ophthalmic surgical probe, reusable
Inami Hook Micro Trabeculotomy, ab interno, TANITO, Shoji Edition, Left
Diamatrix
M-2220L
In Commercial Distribution

  • 00810163790362 ()
M-2220L

  • Ophthalmic surgical probe, reusable
Noguchi Lens Grabber II, Short
Diamatrix
DS-2022S
In Commercial Distribution

  • 00810163790256 ()
DS-2022S

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
HF Monopolar Cable, with Big Bovie Plug, for use with Surgical Direct Flexible Electrodes
Surgical Direct, Inc.
SD1261998U
In Commercial Distribution

  • B382SD1261998U0 ()
SD1261998U

  • Endoscope sheath, reusable
5mm 33cm Metzenbaum Scissor, Curved, Rotatable, with Insulated, Non Locking HF Handle, Flush Port
Surgical Direct, Inc.
SD146792.100
In Commercial Distribution

  • B382SD1467921000 ()
SD146792.100

  • Flexible endoscopic tissue manipulation forceps, single-use
5mm 33cm Metzenbaum Scissor, Curved, Rotatable, with Insulated, Non Locking HF Handle, Flush Port
Surgical Direct, Inc.
SD146792
In Commercial Distribution

  • B382SD1467920 ()
SD146792

  • Flexible endoscopic tissue manipulation forceps, single-use
5mm 32cm Andrew Babcock Forcep, Non-Locking, Insulated, Stainless Steel Handle, Rotating With HF Pos
Surgical Direct, Inc.
SD88882
In Commercial Distribution

  • B382SD888820 ()
SD88882

  • Laparoscopic tissue manipulation forceps/working-channel
Jet Port Plus Silicone Kit HF with 8.4F x 750 mm Attachable Silicone Catheter
PFM MEDICAL INCORPORATED
616.463.1080-A
In Commercial Distribution

  • 07640110981788 ()
  • 07640110987643 ()


  • Vascular port/catheter
Tita Jet Light PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
PFM MEDICAL INCORPORATED
616.362.2080-A
In Commercial Distribution

  • 07640110981276 ()
  • 07640110987513 ()


  • Vascular port/catheter
Jet Port Plus PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
PFM MEDICAL INCORPORATED
616.363.2080-A
In Commercial Distribution

  • 07640110981283 ()
  • 07640110987506 ()


  • Vascular port/catheter
Tapered Dissecting Forceps, Monopolar HF Port, Dual Action Jaw, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-204
Not in Commercial Distribution

  • H834352041 ()
  • 10381780152156 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
MARYLAND Dissector, Curved Dual Action Jaws, Monopolar HF Port, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-201
Not in Commercial Distribution

  • H834352011 ()
  • 10381780152149 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Supercut Scissors, Straight Single Action Jaw, Monopolar HF Port, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-302
Not in Commercial Distribution

  • H834353021 ()
  • 10381780152835 ()


  • Rigid endoscopic scissors, reusable
MONOPOLAR SUCTION / IRRIGATION HANDLE PISTOL WITH SLIDING VALVE HF PLUG AND UNIVERSAL TUBE CONNECTOR
Gimmi GmbH
T.0130.00
In Commercial Distribution

  • 04049047097198 ()
T.0130.00

  • Electrosurgical handpiece, reusable
PowerPICC SOLO HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray
Bard Access Systems, Inc.
9395108Q
In Commercial Distribution

  • 10801741035897 ()
  • 00801741035890 ()

  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
9395108Q

  • Peripherally-inserted central venous catheter
The Ceramill M-Plant module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. Ceramill M-Plant is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.1
In Commercial Distribution

  • 04260521363619 ()


  • Dental milling system, CAD/CAM, chairside
  • CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.2
In Commercial Distribution

  • 04260521363534 ()


  • Dental milling system, CAD/CAM, chairside
  • CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.1
In Commercial Distribution

  • 04260521363527 ()


  • Dental milling system, CAD/CAM, chairside
  • CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.0
In Commercial Distribution

  • 04260521363510 ()


  • CAD/CAM software
  • Dental milling system, CAD/CAM, chairside
ECG monitor 1 to 2 adaptor cable/MECG+FECG/3-lead/060-522+039/0.18+0.18M/Tracelogix Co
Unimed Medical Supplies, Inc.
TL145-00A-136
In Commercial Distribution

  • 06945664885355 ()


  • Electrical-only medical device connection cable, reusable
LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761601 ()
70335-000208

  • Physiologic-monitoring defibrillation system
LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761595 ()
70335-000209

  • Physiologic-monitoring defibrillation system
Safety Deluxe bone Marrow Biopsy Tray with Snare-it marrow acquisition Cannula
ROBERT BUSSE & CO., INC.
989
Not in Commercial Distribution

  • 00849233013841 ()
  • 10849233013848 ()
989

  • Bone marrow biopsy procedure kit
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1404CF)
VATECH CO., LTD.
PHT-35LHS
Not in Commercial Distribution

  • 08800016401325 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
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