Neurosurgical Paddie
Regulation 882.4700
0510(k)s in 12 months (24 all time)
2recalls in 12 months (78 all time)
74recalls that name a 510(k)
Top companies in HBA
| Company | 510(k)s | Recalls |
|---|---|---|
| American Surgical Company, LLC | 2 | 50 |
| Integra LifeSciences Corporation | 1 | 23 |
| American Silk Sutures, Inc. | 4 | 0 |
| Codman & Shurtleff, Inc. | 1 | 3 |
| Medline Industries, Inc. | 1 | 2 |
| Ultracell Medical Technologies, Inc. | 3 | 0 |
| Aesculap | 2 | 0 |
| American Surgical Sponges | 1 | 0 |
| Harod Enterprises, Inc. | 1 | 0 |
| I M, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 4 mm x 50 mm
Ref Number: 63-05
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot-J 15 mm x 20 mm
Ref Number: 63-04J (Japan Only)
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 4 mm x 50 mm
Ref Number: 63-05
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot non-xray 10 mm x 13 mm
Ref Number: 63-03 non-xray
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 10 mm x 13 mm
Ref Number: 63-03
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot non-xray 5 mm x 13 mm
Ref Number: 63-02 non-xray
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 5 mm x 13 mm
Ref Number: 63-02
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot-J 5 mm x 8 mm
Ref Number: 63-01J (Japan Only)
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot non-xray 5 mm x 8 mm
Ref Number: 63-01 Non X-Ray
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 5 mm x 8 mm
Ref Number: 63-01
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/2" x 2"
Ref Number: 60-29
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1.5" x 3"
Ref Number: 60-22
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 3" x 3"
Ref Number: 60-15
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1" x 3"
Ref Number: 60-13
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1" x 1"
Ref Number: 60-12
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/2" x 3"
Ref Number: 60-09
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/2" x 1.5"
Ref Number: 60-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/2" x 1"
Ref Number: 60-07
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/2" x 1/2"
Ref Number: 60-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/4" x 3"
Ref Number: 60-04
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/4" x 1/4"
Ref Number: 60-02
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/2" x 1.5"
Ref Number: 20-06S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K854713 |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/2" x 1"
Ref Number: 20-05S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K854713 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 30mm x 70mm
Ref: 63-10
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 15mm x 20mm
Ref: 63-04
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Oct 20, 2010 | Codman & Shurtleff, Inc. Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card)
Product code: 24-5403 Terminated |
HBA | K880402 |
| Oct 20, 2010 | Codman & Shurtleff, Inc. Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box)
Product code: 80-1399 Terminated |
HBA | K880402 |
| Oct 20, 2010 | Codman & Shurtleff, Inc. Codman 5/16" Round Surgical Patties
(20 pouches of 10 patties per box)
Product code: 80-1396 Terminated |
HBA | K880402 |
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