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ZeroG 3D is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The ZeroG 3D System is intended to assist subjects who have experienced neurological and orthopedic injures as they practice therapeutic activities related to walking and balance activities. ZeroG 3D can also be used to train subjects ambulating on a treadmill. ZeroG 3D should never be used to lift and transport subjects and should never be connected to inanimate objects. ZeroG 3D should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG 3D training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZG3D-001
In Commercial Distribution
- 00850018836265 ()
- Gait rehabilitation frame, electric
The BabyG Early Mobilization System is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The BabyG System is intended to assist subjects weighing 50 pounds or less as they practice therapeutic activities related to walking and balance activities. BabyG should never be used to lift and transport subjects and should never be connected to inanimate objects. BabyG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the BabyG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
BG-001
In Commercial Distribution
- 00850018836258 ()
- Gait rehabilitation frame, electric
The ZeroG-Lite system is intended to assist patients with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Lite should never be used to lift and transport patients, and should never be connected to inanimate objects. ZeroG-Lite should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG-Lite training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGL-V3
In Commercial Distribution
- 00850018836234 ()
- Gait rehabilitation frame, electric
The ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Passive should never be connected to inanimate objects. ZeroG-Passive should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use.
ARETECH, LLC
ZGP-110
In Commercial Distribution
- 00850018836067 ()
- Gait rehabilitation frame, manual
The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer.
The Ovation 700 model allows for a patient weight capacity of up to 700 pounds with a dynamic body-weight support range of 25 to 300 pounds.
ARETECH, LLC
OV-700
In Commercial Distribution
- 00850018836043 ()
- Gait rehabilitation frame, electric
The ZeroG Gait & Balance System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG can also be used to train subjects ambulating on a treadmill. ZeroG should never be used to lift and transport subjects, and should never be connected to inanimate objects. ZeroG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGGB-V3
In Commercial Distribution
- 00850018836012 ()
- Gait rehabilitation frame, electric
The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer.
The Ovation 400 model allows for a patient weight capacity of up to 400 pounds with a dynamic body-weight support range of 10 to 200 pounds.
ARETECH, LLC
OV-400
In Commercial Distribution
- 00850018836029 ()
- Gait rehabilitation frame, electric
Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Intera Oncology Inc.
AP-03000H
In Commercial Distribution
- 00850014110147 ()
- Total Volume: 30 Milliliter
AP03000H
- Implantable intrathecal infusion pump, nonprogrammable
Powered gait trainer and transfer device
RIFTON EQUIPMENT
K660
In Commercial Distribution
- 00858101008292 ()
- Gait rehabilitation electronic walker
The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
PICOLA-SCINTRON
In Commercial Distribution
- 04260484140074 ()
- Stationary gamma camera system
The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
SYNGULA-SCINTRON
In Commercial Distribution
- 04260484140043 ()
- Stationary gamma camera system
The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to
perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients. The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101 01 3. The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.
MiE medical imaging electronics GmbH
ECAM-SCINTRON
In Commercial Distribution
- 04260484140036 ()
- Stationary gamma camera system
830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution
- 00195278788252 ()
5376204-33
- Stationary gamma camera system
MyoSPECT ES to MyoSPECT Upgrade kit
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BS
In Commercial Distribution
- 00195278722546 ()
5941445
- Stationary gamma camera system
MyoSPECT ES MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BD
In Commercial Distribution
- 00195278488626 ()
5875815-40
- Stationary gamma camera system
MyoSPECT MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BC
In Commercial Distribution
- 00195278488619 ()
5875815-30
- Stationary gamma camera system
MyoSPECT GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AA
In Commercial Distribution
- 00195278421586 ()
5875815-10
- Stationary gamma camera system
MyoSPECT ES GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AB
In Commercial Distribution
- 00195278421579 ()
5875815-20
- Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000YT
In Commercial Distribution
- 00840682121644 ()
- Stationary gamma camera system
TANDEM GANTRY-B615 Medical Device
GE Hualun Medical Systems Co., Ltd
5376496-15
In Commercial Distribution
- 00840682117869 ()
- Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100JY
In Commercial Distribution
- 00840682115292 ()
- Stationary gamma camera system
B615 to D630 upgrade kits option with new ROTOR
GE Hualun Medical Systems Co., Ltd
H2401XF
In Commercial Distribution
- 00840682145503 ()
H2401XF
- Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution
- 00840682140829 ()
- Stationary gamma camera system
D630 NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NM 630
In Commercial Distribution
- 00840682139274 ()
- Stationary gamma camera system
D615 NM GANTRY 3_8 WITH NEW ROTOR TOP - MEA
GE Hualun Medical Systems Co., Ltd
NM 615
In Commercial Distribution
- 00840682139267 ()
- Stationary gamma camera system
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003034 ()
203511 SD
- Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003027 ()
- Length: 30 Millimeter
- Length: 35 Millimeter
- Length: 40 Millimeter
- Length: 45 Millimeter
- Length: 50 Millimeter
- Length: 55 Millimeter
- Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511
- Intraurethral valve/pump
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003010 ()
403507
- Intraurethral valve/pump
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003003 ()
203511 SD
- Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003002 ()
- Length: 60 Millimeter
- Length: 55 Millimeter
- Length: 50 Millimeter
- Length: 45 Millimeter
- Length: 40 Millimeter
- Length: 35 Millimeter
- Length: 30 Millimeter
203511
- Intraurethral valve/pump
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003001 ()
403507
- Intraurethral valve/pump
UFC GANTRY FINAL ASSEMBLY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000SA
In Commercial Distribution
- 00840682105286 ()
- Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry UPG
In Commercial Distribution
- 00840682138758 ()
- Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Biopsy
In Commercial Distribution
- 00840682138741 ()
- Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry
In Commercial Distribution
- 00840682138697 ()
- Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H2401JF
In Commercial Distribution
- 00840682123761 ()
- Stationary gamma camera system
Vector Gait and Safety System, Base Model
BIONESS INC.
VEC-3000
In Commercial Distribution
- 00815962020283 ()
- Gait rehabilitation frame, manual
Vector Trolley Assembly, Elite Model
BIONESS INC.
VEC-1100
In Commercial Distribution
- 00815962020276 ()
- Gait rehabilitation frame, electric
Vector Gait and Safety System
BIONESS INC.
VEC-1000
In Commercial Distribution
- 00815962020269 ()
- Gait rehabilitation frame, electric
No Description
HOCOMA AG
V2.0
In Commercial Distribution
- 07640174660230 ()
31585
- Mobile gait rehabilitation system, harness-support
STERILE-R
Dynarex Corporation
42401
In Commercial Distribution
- 00810180841276 ()
- 00840117337329 ()
- 00840117335073 ()
- Assisted reproduction cryotube
STERILE-R
Dynarex Corporation
42400
In Commercial Distribution
- 00810180841269 ()
- 00840117337312 ()
- 00840117335066 ()
- Assisted reproduction cryotube
CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution
- 00893727002118 ()
- 10893727002115 ()
40709
- Assisted reproduction cryotube
Device for oocyte collection
LABORATOIRE CCD
HOC COLLECTION VIAL 30ML
In Commercial Distribution
- 03700111425866 ()
- 03700111400863 ()
- Total Volume: 30 Milliliter
1302001
- Assisted reproduction cryotube
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10413009
In Commercial Distribution
- 04056869002729 ()
- Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution
- 04056869001272 ()
8419009..
- Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910501
In Commercial Distribution
- 04056869001265 ()
- Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910500
In Commercial Distribution
- 04056869001258 ()
- Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08717741
In Commercial Distribution
- 04056869001166 ()
- Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275879
In Commercial Distribution
- 04056869001159 ()
- Stationary gamma camera system