Panels › General, Plastic Surgery › Product code GFD · Class 1
Dermatome
Regulation 878.4820
0510(k)s in 12 months (12 all time)
2recalls in 12 months (22 all time)
0recalls that name a 510(k)
Top companies in GFD
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Surgical Inc | 0 | 15 |
| Integra LifeSciences Corp. | 0 | 4 |
| KCI USA, INC. | 0 | 2 |
| Aesculap, Inc. | 1 | 0 |
| Davol, Inc. | 1 | 0 |
| Depuy Intl., Ltd. | 1 | 0 |
| Downs Surgical , Ltd. | 1 | 0 |
| Dsp Worldwide | 1 | 0 |
| Exsurco Medical | 0 | 1 |
| Mattioli Engineering, Srl | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2025 | Zimmer Surgical Inc Zimmer Dermatome AN, Model/Catalog Number: 88710100 Open, Classified |
GFD | None listed |
| Dec 15, 2025 | Zimmer Surgical Inc Zimmer Air Dermatome, Model/Catalog Number: 00880100100 Open, Classified |
GFD | None listed |
| Oct 6, 2023 | Zimmer Surgical Inc Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capab Open, Classified |
GFD | None listed |
| Sep 12, 2020 | Integra LifeSciences Corp. Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for pro Terminated |
GFD | None listed |
| Sep 12, 2020 | Integra LifeSciences Corp. Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional Terminated |
GFD | None listed |
| Sep 12, 2020 | Integra LifeSciences Corp. 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/ Terminated |
GFD | None listed |
| Jun 8, 2018 | Zimmer Surgical Inc Zimmer Dermatone AN, Model No. 88710100 Terminated |
GFD | None listed |
| Apr 17, 2018 | Exsurco Medical Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004 Terminated |
GFD | None listed |
| Nov 5, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, wh Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00.
Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plat Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 .
Width plates is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01.
The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00.
The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is pack Terminated |
GFD | None listed |
| Jan 7, 2015 | KCI USA, INC. CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25
The CelluTome Epidermal Harvesting System is intended to repr Terminated |
GFD | None listed |
| Sep 29, 2014 | KCI USA, Inc. CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 Terminated |
GFD | None listed |
| Jun 5, 2013 | Zimmer Surgical Inc Zimmer Air Dermatome II, REF 00-8851-001-01
handpiece, w/o hose, Rx, non-sterile
grafting instruments intended to provide variable graft thickness and width capabilities. Terminated |
GFD | None listed |
| Jun 5, 2013 | Zimmer Surgical Inc Zimmer Air Dermatome II, REF 00-8851-001-00
handpiece
Rx, non-sterile
grafting instruments intended to provide variable graft thickness and width capabilities Terminated |
GFD | None listed |
| Jun 5, 2013 | Zimmer Surgical Inc The Zimmer Air Dermatome, REF 00- 8801- 001- 00 ,
Rx, non-sterile
grafting instruments intended to provide variable graft thickness and width capabilities Terminated |
GFD | None listed |
| May 20, 2011 | Integra LifeSciences Corp. Universal Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt.
The Integra Padgett Dermatomes Terminated |
GFD | None listed |
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