NeuroAlign software
Medivis, Inc.
MEDIVIS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015536273 | 3015536273 | MEDIVIS, INC. | 1 | N | 2026-01-01 | 174 5th Ave Fl 2 New York NY US 10010 |
| 2031052 | 3001236769 | MEDIVISION, INC. | 1 | N | 2020-04-25 | 4883 E la Palma Ave Ste 503 ANAHEIM CA US 92807 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 53173 | 1972751547 | K984434 | MEDIVISION LAPAROSCOPE | GCJ | 1999-03-17 |
| 53173 | 2067386907 | K982659 | MEDIVISION HYSTEROSCOPE | HIH | 1998-10-07 |
| 53173 | 2050546557 | K982620 | MEDIVISION CYSTOSCOPE | FAJ | 1998-09-30 |
| 53173 | 1757016489 | K971996 | MEDIVISION ARTHROSCOP | HRX | 1997-07-31 |
| 53173 | 1799028023 | K971995 | MEDIVISION SINOSCOPE | EOB | 1997-06-26 |
| 231024 | 1799102902 | K233725 | Spine Navigation System | OLO | 2024-07-26 |
| 231024 | 1128396023 | K231897 | NeuroAlign software | HAW | 2025-10-21 |
| 231024 | 1537177783 | K190764 | SurgicalAR | LLZ | 2019-05-13 |
Product Codes Associated With Registrations#
PMN#
Spine Navigation System
Medivis, Inc.
SurgicalAR
MEDIVIS, Inc.
IRI INTEGRATED RETINAL IMAGER
MEDIVISION MEDICAL IMAGING, LTD.
MEDIVISION IGS SYSTEM
MEDIVISION (U.S.A.), INC.
MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
MEDIVISION ENDOSCOPY
MEDIVISION LAPAROSCOPE
MEDIVISION SCOPE SERVICE CENTER, INC.
MEDIVISION HYSTEROSCOPE
MEDIVISION SCOPE SERVICE CENTER, INC.
MEDIVISION CYSTOSCOPE
MEDIVISION SCOPE SERVICE CENTER, INC.
MEDIVISION ARTHROSCOP
MEDIVISION SCOPE SERVICE CENTER, INC.
MEDIVISION SINOSCOPE
MEDIVISION SCOPE SERVICE CENTER, INC.
CAMVISION 1000
MEDIVISION MEDICAL IMAGING, LTD.
ANGIOVISION 1000
MEDIVISION MEDICAL IMAGING, LTD.
ANGIOVISION VIEWING STATION
MEDIVISION MEDICAL IMAGING, LTD.
GUDID#
SurgicalAR - 1.1.0.0
2020-11-13
MEDIVISION - CYSTOSCOPEMediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.HYSTEROSCOPEMediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery.
2016-12-14
MEDIVISION - CYSTOSCOPEMediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.HYSTEROSCOPEMediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery.
2016-12-14
MEDIVISION - CYSTOSCOPEMediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.HYSTEROSCOPEMediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery.
2016-12-14
MEDIVISION - CYSTOSCOPEMediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.HYSTEROSCOPEMediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery.
2016-12-14
MEDIVISION - CYSTOSCOPEMediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.HYSTEROSCOPEMediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery.
2016-12-14
MEDIVISION - CYSTOSCOPEMediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.HYSTEROSCOPEMediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery.
2016-12-14
MEDIVISION - ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
2016-12-14
MediVision - ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
2016-12-14
MediVision - ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
2016-12-07
MediVision - ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
2016-12-14
MEDIVISION - ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
2016-12-14
MEDIVISION - ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
2016-12-14
MEDIVISION - ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
2016-12-14
MEDIVISION - ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
2016-12-14
MEDIVISION - ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
2016-12-14
MEDIVISION - ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
2016-12-14
MEDIVISIION - ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
2016-12-14
PureDefense Surgical Mask - Non-woven face mask, with ties, intended for single use by operating room personnel and other general health care workers to protect patients and healthcare workers against the transfer of microorganisms, blood and body fluids, and particulate materials.
2020-05-12
PureDefense Surgical Mask - Non-woven Face Mask with ear loops, intended for single use by operating room personnel and other general health care workers to protect patients and healthcare workers against transfer of microorganisms, blood and body fluids and particulate materials
2020-05-12
MEDIVISION - The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic procedures, such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The Laparoscope may be attached to hand-held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The Laparoscope is designed to pass through standard laparoscopic and thoracoscopic cannulas to gain access to the subject surgical site.
2016-12-14
MEDIVISION - The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic procedures, such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The Laparoscope may be attached to hand-held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The Laparoscope is designed to pass through standard laparoscopic and thoracoscopic cannulas to gain access to the subject surgical site.
2016-12-14
MEDIVISION - The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic procedures, such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The Laparoscope may be attached to hand-held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The Laparoscope is designed to pass through standard laparoscopic and thoracoscopic cannulas to gain access to the subject surgical site.
2016-12-14
MEDIVISION - The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic procedures, such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The Laparoscope may be attached to hand-held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The Laparoscope is designed to pass through standard laparoscopic and thoracoscopic cannulas to gain access to the subject surgical site.
2016-12-14
MEDIVISION - The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic procedures, such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The Laparoscope may be attached to hand-held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The Laparoscope is designed to pass through standard laparoscopic and thoracoscopic cannulas to gain access to the subject surgical site.
2016-12-14
MEDIVISION - The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic procedures, such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The Laparoscope may be attached to hand-held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The Laparoscope is designed to pass through standard laparoscopic and thoracoscopic cannulas to gain access to the subject surgical site.
2016-12-14