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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RING FIXATION FLIERINGA 20MM
Bausch & Lomb Incorporated
E4034 20
In Commercial Distribution

  • 00757770431403 ()
E4034 20

  • Flieringa ophthalmic ring
CANNULA ANGLED MCINTYRE
Bausch & Lomb Incorporated
E4395 20
In Commercial Distribution

  • 00757770421572 ()
E4395 20

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Implant pick-up
MEDENTiKA GmbH
T 20
In Commercial Distribution

  • 04251574829153 ()
  • EMKAT209 ()

  • compatible with DENTSPLY Implants / XiVE®* S
T 20

  • Dental implant suprastructure, temporary, preformed, reusable
Implant pick-up
MEDENTiKA GmbH
S 20
In Commercial Distribution

  • 04251574827456 ()
  • EMKAS209 ()

  • compatible with DENTSPLY Implants / ASTRA TECH OsseoSpeed®* TX
S 20

  • Dental implant suprastructure, temporary, preformed, reusable
Implant pick-up
MEDENTiKA GmbH
R 20
In Commercial Distribution

  • 04251574825483 ()
  • EMKAR209 ()

  • compatible with Zimmer Dental / Tapered Screw-Vent®*
R 20

  • Dental implant suprastructure, temporary, preformed, reusable
HRA TRIAL SZ. 48/20
Smith & Nephew, Inc.
TRL-900-48/20
In Commercial Distribution

  • 00885556837504 ()
TRL-900-48/20

  • Humeral head prosthesis trial, reusable
HRA SHAPER SZ. 48/20
Smith & Nephew, Inc.
SHP-900-48/20
In Commercial Distribution

  • 00885556837344 ()
SHP-900-48/20

  • Bone cutter
PROXIMAL PHALANX SURFACE REAMER SZ. 10/20
Smith & Nephew, Inc.
PSR-890-10/20
In Commercial Distribution

  • 00885556828373 ()
PSR-890-10/20

  • Bone-resection orthopaedic reamer, reusable
nextaro® v, 20/20 (with 15 µm filter, nominal)
sfm medical devices GmbH
20027
In Commercial Distribution

  • 04063574200272 ()


  • Medication transfer set
No Description
ZIRKONZAHN SRL
ZRAB1551
In Commercial Distribution

  • D800ZRAB1551 ()


  • Dental bridge, ceramic
No Description
Baylis Medical Technologies Inc
PSZ-400-311
Not in Commercial Distribution



  • Arthroscopic surgical procedure kit, non-medicated, single-use
20/30 PRIORITY PACK Accessory Kit includes INDEFLATOR Inflation Device 30 atm 20 cc / Rotating Hemostatic Valve .115 " / Guide Wire Introducer / Torque Device
ABBOTT VASCULAR INC.
1000186-115
In Commercial Distribution

  • 08717648015274 ()
1000186-115

  • Catheter/overtube balloon inflator, single-use
Reagents associated to API 20 E™ (20 100/20 160), API® 10 S (10 100), API® 20 NE (20 050), API® Staph (20 500), API® Coryne (20 900), API® Campy (20 800), ID 32 STAPH (32 500), rapid ID 32 A (32 300)
BIOMERIEUX SA
70442
In Commercial Distribution

  • 03573026099671 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent
resorbable porous calcium phosphate bone void filler 25 x 100 x 8mm; 20 cc
Pioneer Surgical Technology, Inc.
90-400-251008
Not in Commercial Distribution

  • 00846468087128 ()
90-400-251008

  • Bone matrix implant, composite
INJECTION GUN FOR MONOJECT TOOMEY 60CC SYRINGE
BLACK & BLACK SURGICAL, INC.
B89IGS-60CC
In Commercial Distribution

  • 00840329814359 ()
B89IGS-60CC

  • Syringe autofill kit
INJECTION GUN SET, FOR 3CC, 5CC, 10CC BD SYRINGE
BLACK & BLACK SURGICAL, INC.
B89IGS-3510CC
In Commercial Distribution

  • 00840329814342 ()
B89IGS-3510CC

  • Syringe autofill kit
The AUTO-FILL Syringe Kit is indicated for introduction of dilute lidocaine solutions into the subcutaneous tissue for the purposes of local anesthesia.
Vascular Solutions, Inc.
7600
Not in Commercial Distribution

  • M20676000 ()
  • M20676001 ()


  • Syringe autofill kit
Progesterone CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10638189
In Commercial Distribution

  • 00630414986159 ()
LPWCVM(D)

  • Progesterone IVD, control
TSH CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388157
In Commercial Distribution

  • 00630414979458 ()
LTSCVM

  • Thyroid stimulating hormone (TSH) IVD, control
PTH Intact CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388105
In Commercial Distribution

  • 00630414979410 ()
LPPCVM

  • Parathyroid hormone (PTH) IVD, control
PSA CVM - IMMULITE – CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10713726
In Commercial Distribution

  • 00630414601946 ()
LPTSCVM

  • Complexed prostate specific antigen (cPSA) IVD, control
Androstenedione CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373680
In Commercial Distribution

  • 00630414978031 ()
LAOCVM

  • Androstenedione IVD, control
Troponin I CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373707
In Commercial Distribution

  • 00630414971391 ()
LTICVM

  • Troponin I IVD, control
Calcitonin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373685
In Commercial Distribution

  • 00630414971186 ()
LCLCVM

  • Procalcitonin (PCT) IVD, control
CEA CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373684
In Commercial Distribution

  • 00630414971179 ()
LCECVM

  • Carcinoembryonic antigen (CEA) IVD, control
BR-MA - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373682
In Commercial Distribution

  • 00630414971155 ()
LBRCVM

  • Cancer antigen 15-3 (CA15-3) IVD, control
AFP CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373681
In Commercial Distribution

  • 00630414971148 ()
LAPCVM

  • Alpha-fetoprotein (AFP) IVD, control
No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10707265
In Commercial Distribution

  • 00630414947921 ()
LUE3CVM(D)

  • Free estriol (oestriol) IVD, control
CapnoVue Scope O2/CO2 Mask with Luer style connector
SALTER LABS
4745-14-15
In Commercial Distribution

  • 10607411971416 ()
  • 00607411971419 ()

  • Adult
4745-14-15

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue Scope O2/CO2 Mask with Luer style connector
SALTER LABS
4745-7-7
In Commercial Distribution

  • 10607411971409 ()
  • 00607411971402 ()

  • Adult
4745-7-7

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue M1 Mask (Pedatric). Single patient use.
SALTER LABS
4733-7-0
In Commercial Distribution

  • 10607411971379 ()
  • 00607411971372 ()

  • Pediatric
4733-7-0

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue M1 Mask (Adult). Single patient use.
SALTER LABS
4737TG-14-0
In Commercial Distribution

  • 10607411971362 ()
  • 00607411971365 ()

  • Adult
4737TG-14-0

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue M1 Mask (Adult). With thread grip. Single patient use.
SALTER LABS
4737TG-7-0
In Commercial Distribution

  • 10607411971355 ()
  • 00607411971358 ()

  • Adult
4737TG-7-0

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue M1 Mask (Adult). Single patient use.
SALTER LABS
4737-14-0
In Commercial Distribution

  • 10607411971348 ()
  • 00607411971341 ()

  • Adult
4737-14-0

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue M1 Mask (Adult). Single patient use.
SALTER LABS
4737-7-0
In Commercial Distribution

  • 10607411971331 ()
  • 00607411971334 ()

  • Pediatric
4737-7-0

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue M1 Mask (Infant). Single patient use.
SALTER LABS
4721-7-0
In Commercial Distribution

  • 10607411971324 ()
  • 00607411971327 ()

  • Infant
4721-7-0

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue M1 Mask (Pediatric). Single patient use.
SALTER LABS
4723-7-0
In Commercial Distribution

  • 10607411971317 ()
  • 00607411971310 ()

  • Pediatric
4723-7-0

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue M1 Mask (Adult) with thread grip. Single patient use.
SALTER LABS
4727TG-14-0
In Commercial Distribution

  • 10607411971300 ()
  • 00607411971303 ()

  • Pediatric
4727TG-14-0

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue M1 Mask (Adult) with thread grip. Single patient use.
SALTER LABS
4727TG-7-0
In Commercial Distribution

  • 10607411971294 ()
  • 00607411971297 ()

  • Pediatric
4727TG-7-0

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue M1 Mask (Adult). Single patient use.
SALTER LABS
4727-14-0
In Commercial Distribution

  • 10607411971287 ()
  • 00607411971280 ()

  • Pediatric
4727-14-0

  • Nasal oxygen cannula, carbon-dioxide-sampling
CapnoVue M1 Mask (Adult). Single patient use.
SALTER LABS
4727-7-0
In Commercial Distribution

  • 10607411971270 ()
  • 00607411971273 ()

  • Pediatric
4727-7-0

  • Nasal oxygen cannula, carbon-dioxide-sampling
Paired Subdermal Electrode YE, 18x2.5mm
Stryker Leibinger GmbH & Co. KG
5140-534-629
In Commercial Distribution

  • 37613327298124 ()
  • 07613327298123 ()

  • Offset: 2.5 Millimeter
  • Length: 18.0 Millimeter
5140-534-629

  • Subdermal needle electrode
Paired Subdermal Electrode YE, 12x2.5mm
Stryker Leibinger GmbH & Co. KG
5140-534-624
In Commercial Distribution

  • 37613327298117 ()
  • 07613327298116 ()

  • Offset: 2.5 Millimeter
  • Length: 12.0 Millimeter
5140-534-624

  • Subdermal needle electrode
Paired Subdermal Electrode BU, 12x2.5mm
Stryker Leibinger GmbH & Co. KG
5140-534-621
In Commercial Distribution

  • 37613327298094 ()
  • 07613327298093 ()

  • Length: 12.0 Millimeter
  • Offset: 2.5 Millimeter
5140-534-621

  • Subdermal needle electrode
Paired Subdermal Electrode RD, 18x2.5mm
Stryker Leibinger GmbH & Co. KG
5140-534-625
In Commercial Distribution

  • 37613327298070 ()
  • 07613327298079 ()

  • Offset: 2.5 Millimeter
  • Length: 18.0 Millimeter
5140-534-625

  • Subdermal needle electrode
Paired Subdermal Electrode VT, 18x2.5mm
Stryker Leibinger GmbH & Co. KG
5140-534-627
In Commercial Distribution

  • 37613327298063 ()
  • 07613327298062 ()

  • Offset: 2.5 Millimeter
  • Length: 18.0 Millimeter
5140-534-627

  • Subdermal needle electrode
Paired Subdermal Electrode VT, 12x2.5mm
Stryker Leibinger GmbH & Co. KG
5140-534-622
In Commercial Distribution

  • 37613327298056 ()
  • 07613327298055 ()

  • Length: 12.0 Millimeter
  • Offset: 2.5 Millimeter
5140-534-622

  • Subdermal needle electrode
Paired Subdermal Electrode RD, 12x2.5mm
Stryker Leibinger GmbH & Co. KG
5140-534-620
In Commercial Distribution

  • 37613327298025 ()
  • 07613327298024 ()

  • Length: 12.0 Millimeter
  • Offset: 2.5 Millimeter
5140-534-620

  • Subdermal needle electrode
Paired Subdermal Electrode BU, 18x2.5mm
Stryker Leibinger GmbH & Co. KG
5140-534-626
In Commercial Distribution

  • 37613327298018 ()
  • 07613327298017 ()

  • Length: 18.0 Millimeter
  • Offset: 2.5 Millimeter
5140-534-626

  • Subdermal needle electrode
Needle Electrode Pair VT/BK, 15x1000mm
Stryker Leibinger GmbH & Co. KG
5140-533-638
In Commercial Distribution

  • 37613327292238 ()
  • 07613327292237 ()

  • Length: 15.0 Millimeter
5140-533-638

  • Subdermal needle electrode
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