Panels › General, Plastic Surgery › Product code BWN · Class 1
Table And Attachments, Operating-Room
Regulation 878.4950
0510(k)s in 12 months (20 all time)
1recalls in 12 months (75 all time)
69recalls that name a 510(k)
Top companies in BWN
| Company | 510(k)s | Recalls |
|---|---|---|
| The Anspach Effort, Inc. | 1 | 72 |
| Northwest Surgical Concepts, Inc. | 2 | 0 |
| Alpha Surgical, Inc. | 1 | 0 |
| American Sterilizer Co. | 1 | 0 |
| David Simmonds Co., Inc. | 1 | 0 |
| Dyonics, Inc. | 1 | 0 |
| Edgewater Medical Equipment Systems | 1 | 0 |
| Ets Rene Marzet | 1 | 0 |
| Infinitech, Inc. | 1 | 0 |
| Innovative Orthopedic Technologies, LLC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2016 | The Anspach Effort, Inc. 12.6CM TAPERED ATTACHMENT, BLACK MAX
Product Usage:
Pneumatic system Terminated |
BWN | K974025 |
| Oct 6, 2016 | The Anspach Effort, Inc. 6.1CM ATTACHMENT, BLACK MAX
Product Usage:
Pneumatic system Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. B-SAGITTAL ASSEMBLY
Product Usage:
Pneumatic system Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. 26.65CM ATTACHMENT, BLACK MAX Terminated |
BWN | K974025 |
| Oct 6, 2016 | The Anspach Effort, Inc. 7.5CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. 8CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. 13.5CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. 14CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. 10.5CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. 11CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. 90 DEG RIGHT ANGLE ATTACH, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. CONTRA ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. 9.4CM MICRO REVISION ATTACH, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. 16.5CM MICRO REVISION ATTACH, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. 22CM MICRO REVISION ATTACH, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. KEYLESS DRIVER, BLACK MAX Terminated |
BWN | K974025 |
| Oct 6, 2016 | The Anspach Effort, Inc. 16CM MIN INVASIVE ATTACH, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. ADJUSTABLE DRILL GUIDE, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. GREEN ROTATING CRANIOTOME, BLACK MAX Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. STANDARD CRANIOTOME, BLACK MAX Terminated |
BWN | K974025 |
| Oct 6, 2016 | The Anspach Effort, Inc. LARGE CRANIOTOME, BLACK MAX Terminated |
BWN | K974025 |
| Oct 6, 2016 | The Anspach Effort, Inc. 11.25CM ATTACHMENT, BLACK MAX Terminated |
BWN | K974025 |
| Oct 6, 2016 | The Anspach Effort, Inc. 19CM ATTACHMENT, BLACK MAX Terminated |
BWN | K974025 |
| Oct 6, 2016 | The Anspach Effort, Inc. 7.2cm Adjustable Drill Guide
Product Usage:
Electric system Terminated |
BWN | K011444 |
| Jan 30, 2014 | Merit Medical Systems, Inc. Radial Assist RAD BOARD, used to support the
weight of a patient's arm and supplies for a medical procedure.
The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical p Terminated |
BWN | None listed |
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