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 2, 2026 | QUANTUM OPS Inc Brand Name: ADAPTABLE Beach Chair
Product Name: Beach Chair surgical patient positioner
Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); internal BC-0001 / BC-0220
Software Version Open, Classified |
BWN | None listed |
| Sep 13, 2021 | Innovative Orthopedic Technologies, LLC ARCH Leg Positioning System Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 20.2cm Heavy Duty Long Heavy Short Attachment Terminated |
BWN | K080802 |
| Oct 6, 2016 | The Anspach Effort, Inc. Sagittal MICRO-SAW Terminated |
BWN | K080802 |
| Oct 6, 2016 | The Anspach Effort, Inc. 5.0cm Heavy Duty Short Attachment Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 5.0cm Short Attachment Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. SMALL ATTACHMENT, J-LATCH Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. SMALL ATTACHMENT, JACOBS CHUCK Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. Reciprocating MICRO SAW Terminated |
BWN | K080802 |
| Oct 6, 2016 | The Anspach Effort, Inc. 7.5cm QD Angle Attachment Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 8cm QD Angle Attachment Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 14cm QD Angle Attachment Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 14cm QD Angle Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 10.5cm QD Angle Attachment
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 11cm QD Angle Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. Oscillating MICRO-SAW
Product Usage:
Pneumatic system Terminated |
BWN | K080802 |
| Oct 6, 2016 | The Anspach Effort, Inc. 90 degree Contra Angle Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. 45 degree Contra Angle Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K955084 |
| Oct 6, 2016 | The Anspach Effort, Inc. Otologic Curved Micro
Product Usage:
Pneumatic system Terminated |
BWN | K131053 |
| Oct 6, 2016 | The Anspach Effort, Inc. Sagittal Saw
Product Usage:
Pneumatic system Terminated |
BWN | K080802 |
| Oct 6, 2016 | The Anspach Effort, Inc. 16cm Minimally Invasive Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 8.0CM Heavy Duty Medium Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 8.0cm Medium Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. Minimal Access Straight Driver
Product Usage:
Pneumatic system Terminated |
BWN | K042783 |
| Oct 6, 2016 | The Anspach Effort, Inc. Minimal Access Attachment, BLACK MAX
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Minimal Access Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K042783 |
| Oct 6, 2016 | The Anspach Effort, Inc. Bearing Sleeve, 19CM Straight Taper
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Bearing Sleeve, 15CM Straight Taper
Product Usage:
Pneumatic system Terminated |
BWN | K042783 |
| Oct 6, 2016 | The Anspach Effort, Inc. Bearing Sleeve, 15CM Straight
Product Usage:
Pneumatic system Terminated |
BWN | K042783 |
| Oct 6, 2016 | The Anspach Effort, Inc. Bearing Sleeve, 15CM Curved
Product Usage:
Pneumatic system Terminated |
BWN | K042783 |
| Oct 6, 2016 | The Anspach Effort, Inc. Bearing Sleeve, 10CM Straight
Product Usage:
Pneumatic system Terminated |
BWN | K042783 |
| Oct 6, 2016 | The Anspach Effort, Inc. Bearing Sleeve, 10CM Curved
Product Usage:
Pneumatic system Terminated |
BWN | K042783 |
| Oct 6, 2016 | The Anspach Effort, Inc. 10.5cm Long Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 12.4cm Heavy Duty Long Heavy Short Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K080802 |
| Oct 6, 2016 | The Anspach Effort, Inc. 10.5cm Long Attachment, Non-Tapered End
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 11.0cm Long Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. Keyless Driver
Product Usage:
Pneumatic system Terminated |
BWN | K965080 |
| Oct 6, 2016 | The Anspach Effort, Inc. Chuck Driver System Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. Compact Speed Reducer, 60:1 Black Max Terminated |
BWN | K960630 |
| Oct 6, 2016 | The Anspach Effort, Inc. Compact Speed Reducer, 60:1 Terminated |
BWN | K960630 |
| Oct 6, 2016 | The Anspach Effort, Inc. Pediatric Craniotome Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. Rotating Large Craniotome Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. Large Craniotome
Product Usage:
Pneumatic system Terminated |
BWN | K974025 |
| Oct 6, 2016 | The Anspach Effort, Inc. Rotating Adult Craniotome
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 6.5CM ADLT CRANI, THIN FT PLATE
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. Adult Craniotome
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 6.8cm Controlled Depth Attachment
Product Usage:
Pneumatic system Terminated |
BWN | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. 8.2CM ATTACHMENT, BLACK MAX
Product Usage:
Pneumatic system Terminated |
BWN | K974025 |
| Oct 6, 2016 | The Anspach Effort, Inc. PEDIATRIC CRANIOTOME, BM
Product Usage:
Pneumatic system Terminated |
BWN | K974025 |
| Oct 6, 2016 | The Anspach Effort, Inc. 5.9CM ATTACHMENT, BLACK MAX
Product Usage:
Pneumatic system Terminated |
BWN | K974025 |
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