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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E Supreme Breast Protehsis Size 5
TRULIFE LIMITED
509 5
In Commercial Distribution

  • 00643293000335 ()


  • External breast prosthesis
E Supreme Breast Protehsis Size 4
TRULIFE LIMITED
509 4
In Commercial Distribution

  • 00643293000328 ()


  • External breast prosthesis
E Supreme Breast Protehsis Size 3
TRULIFE LIMITED
509 3
In Commercial Distribution

  • 00643293000311 ()


  • External breast prosthesis
E Supreme Breast Protehsis Size 2
TRULIFE LIMITED
509 2
In Commercial Distribution

  • 00643293000304 ()


  • External breast prosthesis
E Supreme Breast Protehsis Size 1
TRULIFE LIMITED
509 1
In Commercial Distribution

  • 00643293000298 ()


  • External breast prosthesis
Oxygen Sensor
MAXTEC, LLC
R125P03-002
In Commercial Distribution

  • 00853061006906 ()


  • Respiratory oxygen sensor
No Description
HONSUN (NANTONG) CO.,LTD
LD-737
In Commercial Distribution

  • 01697038425005 ()
  • 11697038425002 ()


  • Automatic-inflation electronic sphygmomanometer, portable, finger
Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1 in. x 1.25 in. and are single patient use only.
AMPCARE, LLC
50709ST
In Commercial Distribution

  • 10867786000214 ()
  • 00867786000217 ()
50709ST

  • Transcutaneous electrical stimulation electrode, single-use
Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1.5 in. x 1.75 in. and are single patient use only.
AMPCARE, LLC
50709LT
In Commercial Distribution

  • 00867786000200 ()
  • 10867786000207 ()
50709LT

  • Transcutaneous electrical stimulation electrode, single-use
No Description
Firstar Healthcare Company Limited (Guangzhou)
FS-103
In Commercial Distribution

  • 06942272610300 ()


  • Cardiopulmonary resuscitation mask, reusable
No Description
Medical Measurement Systems B.V.
CIM E
In Commercial Distribution

  • 08717775955641 ()


  • Urodynamic measurement system
No Description
HONSUN (NANTONG) CO.,LTD
LD-737
In Commercial Distribution

  • 01697038425005 ()


  • Automatic-inflation electronic sphygmomanometer, portable, finger
No Description
ESAOTE SPA
120000038
In Commercial Distribution

  • 08056304453891 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
Firstar Healthcare Company Limited (Guangzhou)
FS-103
Not in Commercial Distribution

  • B448FS1030 ()


  • Cardiopulmonary resuscitation mask, reusable
Rotating anode X-ray tube unit for radiography systems
I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA
C339 E
In Commercial Distribution

  • 08059307491402 ()


  • X-ray system tube rotating anode assembly
No Description
Drägerwerk AG & Co. KGaA
8403076
Not in Commercial Distribution

  • 04048675176565 ()


  • Straight/elbow breathing circuit connector, reusable
No Description
IVOCLAR VIVADENT, INC.
592537
Not in Commercial Distribution

  • D7075925370 ()
592537

  • Dental casting noble alloy
BioUniversal E 1oz/31 g
IVOCLAR VIVADENT, INC.
592532
Not in Commercial Distribution

  • D7075925320 ()
592532

  • Dental casting noble alloy
AMC&E 5-lead DIN to Pinch Telemetry Leadset
HYGIA HEALTH SERVICES, INC.
LW-309DS50/5AT
Not in Commercial Distribution

  • 30817357020831 ()
  • 10817357020837 ()


  • Electrocardiographic lead set, reprocessed
AMC&E 3-lead DIN to Pinch Leadset
HYGIA HEALTH SERVICES, INC.
LW-309DS50/3A
Not in Commercial Distribution

  • 30817357020572 ()
  • 10817357020578 ()


  • Electrocardiographic lead set, reprocessed
AMC&E 5-lead DIN to Pinch Leadset
HYGIA HEALTH SERVICES, INC.
LW-309DS50/5A
Not in Commercial Distribution

  • 30817357020480 ()
  • 10817357020486 ()


  • Electrocardiographic lead set, reprocessed
Root canal filling solvant
SEPTODONT SAS SPECIALITES SEPTODONT
01E0260
In Commercial Distribution

  • 03760140703298 ()

  • Total Volume: 13 Milliliter
01E0260

  • Root canal filling-removal solution
E-Handle, AO, Black
MIAMI DEVICE SOLUTIONS LLC
MDS000606AO
In Commercial Distribution

  • 10812269022658 ()
MDS000606AO

  • Surgical instrument handle, non-torque-limiting
  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
e∙Sense® catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
PendraCare International B.V.
Bladder & Urethral Dual Sensor Catheter; Coudé tip shape.
In Commercial Distribution

  • 08718122046302 ()
  • 38718122046303 ()

  • Coudé tip shape
  • 7F Diameter
  • Length: 40 Centimeter
37042105

  • Urodynamic catheter
e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
PendraCare International B.V.
Bladder Single Sensor Catheter; Coudé tip shape
In Commercial Distribution

  • 08718122046296 ()
  • 38718122046297 ()

  • Length: 40 Centimeter
  • 7F Diameter
  • Coudé distal tip shape
37041105

  • Urodynamic catheter
e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
PendraCare International B.V.
Bladder & Urethral Dual Sensor Catheter, straight tip shape
In Commercial Distribution

  • 08718122028339 ()
  • 38718122028330 ()

  • Length: 40 Centimeter
  • 7F Diameter
37042005

  • Urodynamic catheter
e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
PendraCare International B.V.
Bladder, Single Sensor Catheter, Straight tip shape
In Commercial Distribution

  • 08718122028322 ()
  • 38718122028323 ()

  • Length: 40 Centimeter
  • 7F Diameter
37041005

  • Urodynamic catheter
e∙Sense Urodynamic catheters are single use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
PendraCare International B.V.
Abdominal Catheter
In Commercial Distribution

  • 38718122028316 ()
  • 08718122028315 ()

  • Length: 40 Centimeter
  • 7F Diameter
37040005

  • Urodynamic catheter
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 73/28 E
In Commercial Distribution

  • 03662200006090 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 71/28 E
In Commercial Distribution

  • 03662200006083 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 69/28 E
In Commercial Distribution

  • 03662200006076 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 67/28 E
In Commercial Distribution

  • 03662200006069 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 65/28 E
In Commercial Distribution

  • 03662200006052 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 63/28 E
In Commercial Distribution

  • 03662200006045 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 61/28 E
In Commercial Distribution

  • 03662200006038 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 59/28 E
In Commercial Distribution

  • 03662200006021 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 57/28 E
In Commercial Distribution

  • 03662200006014 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 55/28 E
In Commercial Distribution

  • 03662200006007 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 53/28 E
In Commercial Distribution

  • 03662200005994 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 51/28 E
In Commercial Distribution

  • 03662200005987 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 49/28 E
In Commercial Distribution

  • 03662200005970 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 47/28 E
In Commercial Distribution

  • 03662200005963 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 73/22,2 E
In Commercial Distribution

  • 03662200005956 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 71/22,2 E
In Commercial Distribution

  • 03662200005949 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 69/22,2 E
In Commercial Distribution

  • 03662200005932 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 67/22,2 E
In Commercial Distribution

  • 03662200005925 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 65/22,2 E
In Commercial Distribution

  • 03662200005918 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 63/22,2 E
In Commercial Distribution

  • 03662200005901 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 61/22,2 E
In Commercial Distribution

  • 03662200005895 ()


  • Non-constrained polyethylene acetabular liner
NOVAE Dual Mobility Acetabular Cup - CI E polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 59/22,2 E
In Commercial Distribution

  • 03662200005888 ()


  • Non-constrained polyethylene acetabular liner
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