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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FORK X0714112 22 MM BENT RELEASE
MEDTRONIC SOFAMOR DANEK, INC.
X0714112
In Commercial Distribution

  • 00643169545649 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
FORK X0714111 19 MM BENT RELEASE
MEDTRONIC SOFAMOR DANEK, INC.
X0714111
In Commercial Distribution

  • 00643169545632 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-SC1306A
In Commercial Distribution

  • 05060570987151 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-SC1000A
In Commercial Distribution

  • 05060570987090 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-SC1005
In Commercial Distribution

  • 05060570987083 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-SC1000
In Commercial Distribution

  • 05060570987076 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1005A
In Commercial Distribution

  • 05060570987052 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1306A
In Commercial Distribution

  • 05060570983658 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1302A
In Commercial Distribution

  • 05060570983641 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1200A
In Commercial Distribution

  • 05060570983634 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1200
In Commercial Distribution

  • 05060570983627 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1137A
In Commercial Distribution

  • 05060570983610 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1135A
In Commercial Distribution

  • 05060570983603 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1133A
In Commercial Distribution

  • 05060570983597 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1132-01A
In Commercial Distribution

  • 05060570983580 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1132A
In Commercial Distribution

  • 05060570983573 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1131A
In Commercial Distribution

  • 05060570983566 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1130A
In Commercial Distribution

  • 05060570983559 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1129A
In Commercial Distribution

  • 05060570983542 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1127A
In Commercial Distribution

  • 05060570983535 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1123A
In Commercial Distribution

  • 05060570983528 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1120
In Commercial Distribution

  • 05060570983511 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1110
In Commercial Distribution

  • 05060570983504 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1100A
In Commercial Distribution

  • 05060570983498 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1100
In Commercial Distribution

  • 05060570983481 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1005
In Commercial Distribution

  • 05060570983474 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1000A
In Commercial Distribution

  • 05060570983467 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
A-NANO-C1000
In Commercial Distribution

  • 05060570983450 ()


  • Ophthalmic knife, reusable
Blackford Platform v3.0.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
3.0.x
In Commercial Distribution

  • 05060570830150 ()


  • Radiological PACS software
Blackford Platform v2.4.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.4.x
In Commercial Distribution

  • 05060570830112 ()


  • Radiological PACS software
Blackford Dashboard v1.2, monitoring tool for users of the Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.2.x
In Commercial Distribution

  • 05060570830082 ()


  • Radiological PACS software
Blackford Smart Localizer v1.3.x, supplied with Blackford Platform (part of the Blackford Product Family)- previously marketed as the Blackford Registration Application
BLACKFORD ANALYSIS LIMITED
1.3.x
In Commercial Distribution

  • 05060570830075 ()


  • Radiological PACS software
Blackford Registration Application v1.2.x, supplied with Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.2.x
In Commercial Distribution

  • 05060570830013 ()


  • Radiological PACS software
Blackford Platform v2.0.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.0.x
In Commercial Distribution

  • 05060570830006 ()


  • Radiological PACS software
IVF Incubator. Intended to establish a suitable environment for the development of human embryos/blastocysts for the in vitro fertilization (IVF)/assisted reproductive technology (ART) procedures.
RESEARCH INSTRUMENTS LIMITED
G210 InviCell
In Commercial Distribution

  • 05060554120963 ()
K59500

  • Assisted reproduction heater/incubator
IVF Incubator. Intended to establish a suitable environment for the development of human embryos/blastocysts for the in vitro fertilization (IVF)/assisted reproductive technology (ART) procedures.
RESEARCH INSTRUMENTS LIMITED
G210 InviCell
In Commercial Distribution

  • 05060554120956 ()
K59500

  • Assisted reproduction heater/incubator
IVF Incubator. Intended to establish a suitable environment for the development of human embryos/blastocysts for the in vitro fertilization (IVF)/assisted reproductive technology (ART) procedures.
RESEARCH INSTRUMENTS LIMITED
G210
In Commercial Distribution

  • 05060554120123 ()
K59500

  • Assisted reproduction heater/incubator
Décolletage & Neck Device- Boost Branded (The Light Salon)- Black Controller
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510388 ()
112A

  • Cosmetic red-light phototherapy system, home-use
LED Body Panel- Boost Branded- (The Light Salon)- Black Controller
I-SMART DEVELOPMENTS LIMITED
TN19I
In Commercial Distribution

  • 05060534510364 ()
145A

  • Cosmetic red-light phototherapy system, home-use
V1 facemask- Boost Branded (The Light Salon)- Black Controller
I-SMART DEVELOPMENTS LIMITED
TN2010
In Commercial Distribution

  • 05060534510043 ()
111A

  • Cosmetic red-light phototherapy system, home-use
CSP-201 QUIETCAST PAEDIATRIC SAW
DE SOUTTER MEDICAL LIMITED
1286994
In Commercial Distribution

  • 05060528013192 ()
1286994

  • Cast cutter, electrically-powered
diamond knife for eye surgery
Anton Meyer & Co. AG
ME100-C
In Commercial Distribution

  • 05060518823183 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
ME106-C
In Commercial Distribution

  • 05060518823138 ()


  • Ophthalmic knife, reusable
diamond knife for eye surgery
Anton Meyer & Co. AG
ME630
In Commercial Distribution

  • 05060518822629 ()


  • Ophthalmic knife, reusable
Signum cre-active, black, 3 g
Kulzer GmbH
66020058
In Commercial Distribution

  • J014660200580 ()
66020058

  • Dental prosthesis veneer resin
BLADE EX0614060 MIDLIF NARROW 11CM RH
MEDTRONIC SOFAMOR DANEK, INC.
EX0614060
In Commercial Distribution

  • 00643169532571 ()


  • General internal orthopaedic fixation system implantation kit
BLADE EX0614058 MIDLIF NARROW 9CM RH
MEDTRONIC SOFAMOR DANEK, INC.
EX0614058
In Commercial Distribution

  • 00643169532557 ()


  • General internal orthopaedic fixation system implantation kit
BLADE EX0614057 MIDLIF NARROW 8CM RH
MEDTRONIC SOFAMOR DANEK, INC.
EX0614057
In Commercial Distribution

  • 00643169532540 ()


  • General internal orthopaedic fixation system implantation kit
BLADE EX0614056 MIDLIF NARROW 7CM RH
MEDTRONIC SOFAMOR DANEK, INC.
EX0614056
In Commercial Distribution

  • 00643169532533 ()


  • General internal orthopaedic fixation system implantation kit
BLADE EX0614055 MIDLIF NARROW 6CM RH
MEDTRONIC SOFAMOR DANEK, INC.
EX0614055
In Commercial Distribution

  • 00643169532526 ()


  • General internal orthopaedic fixation system implantation kit
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