|
Device |
neurological stereotaxic instrument |
Product Code | HAW |
Regulation Number |
882.4560
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
7D SURGICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BRAINLAB AG |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
1. K190250 Microscope Navigation
|
2. K192703 Cranial Image Guided Surgery System, Navigation So ...
|
3. K201752 Disposable Pre-calibrated Suction
|
4. K210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic ...
|
5. K211544 Trajectory Planning, Elements Trajectory Planning, ...
|
6. K213989 Cranial EM System
|
7. K223288 Cranial Navigation, Navigation Software Cranial, N ...
|
8. K223552 Brainlab Elements – Trajectory Planning (2.6), Ele ...
|
9. K223864 Alignment System Cranial, Alignment Software Crani ...
|
CLEARPOINT NEURO INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
CLEARPOINT NEURO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELEKTA INSTRUMENT AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTRAVENT MEDICAL PARTNERS, LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LOCALITE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTECH S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTECH S.A.S |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC NAVIGATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC NAVIGATION INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC NAVIGATION INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC NAVIGATION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MRI INTERVENTIONS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MRI INTERVENTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NAVINETICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NAVINETICS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAJUNK GMBH MEDIZINTECHNOLOGIE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SINOVATION (BEIJING) MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOTERIX MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNAPTIVE MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THERATAXIS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TONICA ELEKTRONIK A/S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZETA SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZETA SURGICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Brainlab AG |
II |
Oct-06-2020 |
2 |
Brainlab AG |
I |
Apr-15-2019 |
3 |
Elekta Inc |
II |
Apr-29-2020 |
4 |
Elekta Instrument AB |
I |
Apr-16-2024 |
5 |
Elekta Instrument AB |
II |
Mar-30-2023 |
6 |
Elekta Instrument AB |
II |
Jul-10-2020 |
7 |
Globus Medical, Inc. |
II |
Feb-06-2024 |
8 |
MEDTECH SAS |
I |
Oct-25-2021 |
9 |
MEDTECH SAS |
II |
Feb-11-2020 |
10 |
MEDTECH SAS |
I |
Nov-01-2019 |
11 |
Medtronic Navigation, Inc. |
I |
Nov-10-2023 |
12 |
Medtronic Navigation, Inc. |
I |
Jun-02-2023 |
13 |
Medtronic Navigation, Inc. |
I |
Jun-02-2023 |
14 |
Medtronic Navigation, Inc. |
II |
Jan-30-2023 |
15 |
Medtronic Navigation, Inc. |
I |
Dec-22-2021 |
16 |
Medtronic Navigation, Inc. |
II |
Dec-22-2021 |
17 |
Medtronic Navigation, Inc. |
II |
Jul-27-2020 |
18 |
Medtronic Navigation, Inc. |
I |
May-18-2020 |
19 |
Medtronic Navigation, Inc. |
II |
Dec-06-2019 |
20 |
Medtronic Xomed, Inc. |
II |
Oct-21-2021 |
21 |
Navinetics Inc |
II |
Apr-04-2024 |
|
|
|
|