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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anteriors; shade D2; mould Q 62
Merz Dental GmbH
anteriors; shade D2; mould Q 62
In Commercial Distribution

  • D7091984595 ()
1984595

  • Resin artificial teeth
anteriors; shade D2; mould Q 58
Merz Dental GmbH
anteriors; shade D2; mould Q 58
In Commercial Distribution

  • D7091984593 ()
1984593

  • Resin artificial teeth
anteriors; shade D2; mould Q 46
Merz Dental GmbH
anteriors; shade D2; mould Q 46
In Commercial Distribution

  • D7091984586 ()
1984586

  • Resin artificial teeth
8x10.5 16 INST Q CASSETTE, OCEAN BLUE
HU-FRIEDY MFG. CO., LLC
IMN41611Q
Not in Commercial Distribution

  • 10889950067175 ()
IMN41611Q

  • Device sterilization/disinfection container, reusable
8X10.5 12 INST Q CASSETTE, OCEAN BLUE
HU-FRIEDY MFG. CO., LLC
IMN41211Q
Not in Commercial Distribution

  • 10889950066840 ()
IMN41211Q

  • Device sterilization/disinfection container, reusable
INSTRUMENT 922502S Q C STRT PED SPATULA
MEDTRONIC SOFAMOR DANEK, INC.
922502S
In Commercial Distribution

  • 00681490912235 ()


  • General-purpose surgical spatula
INSTRUMENT 922501L Q C LONG SQUARE AWL
MEDTRONIC SOFAMOR DANEK, INC.
922501L
In Commercial Distribution

  • 00681490912211 ()


  • Bone awl, reusable
INSTRUMENT 922501S Q C SHORT SQUARE AWL
MEDTRONIC SOFAMOR DANEK, INC.
922501S
In Commercial Distribution

  • 00681490912204 ()


  • Bone awl, reusable
F&P Pilairo Q Nasal Pillows Mask
FISHER & PAYKEL HEALTHCARE LIMITED
400421
In Commercial Distribution

  • 09420012427076 ()
  • 09420012427069 ()
400421

  • CPAP/BPAP nasal mask, reusable
Zest Q Plus Nasal Mask (Sleep Lab)
FISHER & PAYKEL HEALTHCARE LIMITED
400446SL
In Commercial Distribution

  • 09420012425546 ()
  • 09420012427335 ()
400446SL

  • CPAP/BPAP nasal mask, reusable
Zest Q Standard Nasal Mask (Sleep Lab)
FISHER & PAYKEL HEALTHCARE LIMITED
400445SL
In Commercial Distribution

  • 09420012427328 ()
  • 09420012425539 ()
400445SL

  • CPAP/BPAP nasal mask, reusable
Zest Q Petite Nasal Mask (Sleep Lab)
FISHER & PAYKEL HEALTHCARE LIMITED
400444SL
In Commercial Distribution

  • 09420012427311 ()
  • 09420012425522 ()
400444SL

  • CPAP/BPAP nasal mask, reusable
POP Q Exam Stick Bag of 50
MARINA MEDICAL INSTRUMENTS, INC.
222-222
In Commercial Distribution

  • 00840306824562 ()
  • 00840306824579 ()
222-222

  • Ophthalmic surgical instrument handle, manual
FLWMTR,ALUM,AIR,P.B Q/C,15LPM
Allied Medical, LLC
15006-13-A
In Commercial Distribution

  • 00026072017937 ()


  • Medical gas flowmeter, Thorpe tube
KIT,TOTAL KNEE, VA MEDICAL Q 2
Cardinal Health 200, LLC
PO54TKVAP
In Commercial Distribution

  • 50885425731464 ()
  • 10885425731466 ()
PO54TKVAP

  • Orthopaedic surgical procedure kit, medicated
HA LPL EAR Q S2 SP BG
Ws Audiology Usa, Inc.
EAR Q I2 SP
In Commercial Distribution

  • 04056839027493 ()
10943054

  • Air-conduction hearing aid, behind-the-ear
HA LPL EAR Q S2 SP DBR
Ws Audiology Usa, Inc.
EAR Q I2 SP
In Commercial Distribution

  • 04056839027486 ()
10943055

  • Air-conduction hearing aid, behind-the-ear
HA LPL EAR Q S2 SP GR
Ws Audiology Usa, Inc.
EAR Q I2 SP
In Commercial Distribution

  • 04056839027479 ()
10943056

  • Air-conduction hearing aid, behind-the-ear
HA LPL EAR Q I2 SP BG
Ws Audiology Usa, Inc.
EAR Q I2 SP
In Commercial Distribution

  • 04056839027462 ()
10943057

  • Air-conduction hearing aid, behind-the-ear
HA LPL EAR Q I2 SP DBR
Ws Audiology Usa, Inc.
EAR Q I2 SP
In Commercial Distribution

  • 04056839027455 ()
10943058

  • Air-conduction hearing aid, behind-the-ear
HA LPL EAR Q I2 SP GR
Ws Audiology Usa, Inc.
EAR Q I2 SP
In Commercial Distribution

  • 04056839027448 ()
10943059

  • Air-conduction hearing aid, behind-the-ear
VBR end piece, size Q, right, 8°
Ulrich GmbH & Co. KG
CS 2228-4258-7
Not in Commercial Distribution

  • 04052536004102 ()
CS 2228-4258-7

  • Vertebral body prosthesis
VBR end piece, size Q, left, 8°
Ulrich GmbH & Co. KG
CS 2228-4258-6
Not in Commercial Distribution

  • 04052536004096 ()
CS 2228-4258-6

  • Vertebral body prosthesis
VBR end piece, size Q, right, 5°
Ulrich GmbH & Co. KG
CS 2228-4258-5
Not in Commercial Distribution

  • 04052536004089 ()
CS 2228-4258-5

  • Vertebral body prosthesis
VBR end piece, size Q, left, 5°
Ulrich GmbH & Co. KG
CS 2228-4258-4
Not in Commercial Distribution

  • 04052536004072 ()
CS 2228-4258-4

  • Vertebral body prosthesis
VBR end piece, size Q, left, 0°
Ulrich GmbH & Co. KG
CS 2228-4258-3
Not in Commercial Distribution

  • 04052536004065 ()
CS 2228-4258-3

  • Vertebral body prosthesis
VBR end piece, size Q, right, 0°
Ulrich GmbH & Co. KG
CS 2228-4258-2
Not in Commercial Distribution

  • 04052536004058 ()
CS 2228-4258-2

  • Vertebral body prosthesis
KIT,TOTAL KNEE, VA MEDICAL Q 2
Cardinal Health 200, LLC
PO54TKVA4
In Commercial Distribution

  • 50887488992592 ()
  • 10887488992594 ()
PO54TKVA4

  • Orthopaedic surgical procedure kit, medicated
PROT ACQ/STIM Q/R POD KIT
XLTEK
10384
In Commercial Distribution

  • 00382830011235 ()


  • Electroencephalograph
SFTWR KIT 9733933XOM DICOM SOFTWARE Q/R
MEDTRONIC NAVIGATION, INC.
9733933XOM
In Commercial Distribution

  • 00613994481115 ()


  • Multi-purpose stereotactic surgery system
SFTWR KIT 9733933 DICOM SOFTWARE Q/R
MEDTRONIC NAVIGATION, INC.
9733933
In Commercial Distribution

  • 00613994467072 ()


  • Multi-purpose stereotactic surgery system
GQ-707 DRILL & REAM COMBI HEAD - Q OUTPUT
DE SOUTTER MEDICAL LIMITED
17570
In Commercial Distribution

  • 05051471140417 ()
17570

  • Drilling power tool attachment, basic
Everest MI XT Q Tap, Cannulated Ø8.5mm
K2M, INC.
48112985
In Commercial Distribution

  • 10888857553385 ()
48112985

  • Bone tap, reusable
Everest MI XT Q Tap, Cannulated Ø7.5mm
K2M, INC.
48112975
In Commercial Distribution

  • 10888857553378 ()
48112975

  • Bone tap, reusable
Everest MI XT Q Tap, Cannulated Ø6.5mm
K2M, INC.
48112965
In Commercial Distribution

  • 10888857553361 ()
48112965

  • Bone tap, reusable
Everest MI XT Q Tap, Cannulated Ø5.5mm
K2M, INC.
48112955
In Commercial Distribution

  • 10888857553354 ()
48112955

  • Bone tap, reusable
Everest MI XT Q Tap, Cannulated Ø4.5mm
K2M, INC.
48112945
In Commercial Distribution

  • 10888857553347 ()
48112945

  • Bone tap, reusable
Xia 3/Serrato/ES2 Q Drive Shaft
K2M, INC.
48113201
In Commercial Distribution

  • 10888857552371 ()
48113201

  • Surgical screwdriver, reusable
SCREW, CROSSDRIVE, DRILL FREE, Q STYLE, TI-6AL-4V
KLS-Martin L.P.
01-300-12-09
Not in Commercial Distribution

  • 00888118005748 ()

  • 1.5 X 4 MM THD, TTL=5 MM


  • Craniofacial bone screw, non-bioabsorbable
Salmonella H: g,q For phase inversion
PRO-LAB, INCORPORATED
PLA243
In Commercial Distribution

  • 00817978022435 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
BED CONTROL,HD2, Q PLUG, 8 FEET
Crest Healthcare Supply
BCQYXX
In Commercial Distribution

  • B484BCQYXX0 ()


  • Bed remote control
BED CONTROL,HD2, Q PLUG, 8 FEET
Crest Healthcare Supply
BCQFZZ
In Commercial Distribution

  • B484BCQFZZ0 ()


  • Bed remote control
SuperCure Q Contrast .5g prefilled tips, 30
CENTRIX, INC.
310147
In Commercial Distribution

  • 00817051020112 ()


  • Dental composite resin
SuperCure Q Natural .5g prefilled tips, 30
CENTRIX, INC.
310146
In Commercial Distribution

  • 00817051020105 ()


  • Dental composite resin
No Description
MERIT MEDICAL SYSTEMS, INC.
Q
In Commercial Distribution

  • 10884450719562 ()
  • 00884450719565 ()
  • 20884450719569 ()

  • Gauge-16G
  • Needle Length (cm)-7.5 cm
SSR75S-01

  • Electromagnetic surgical navigation device tracking system
No Description
E.M.S. Electro Medical Systems S.A.
q
In Commercial Distribution

  • 07613353001780 ()
EN-037

  • Ultrasonic dental scaling/debridement system
ShangRing Male Circumcision Device Self-locking
Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
Q
In Commercial Distribution

  • 26939550822207 ()
  • 16939550822200 ()
  • 86939550822209 ()


  • Surgical penis clamp, single-use
The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient’s ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch’s memory can be downloaded through a USB port using the Q Patch Downloader (PC application).
MEDICALGORITHMICS S A
P5HP-AA-ADS
In Commercial Distribution

  • 05903021560124 ()


  • Electrocardiographic ambulatory recorder
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-040
In Commercial Distribution

  • 09348215061746 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-050
In Commercial Distribution

  • 09348215058289 ()


  • Fluted surgical drill bit, reusable
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