ClearanceBrief
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)
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Top companies in GFD

Company510(k)sRecalls
Zimmer Surgical Inc015
Integra LifeSciences Corp.04
KCI USA, INC.02
Aesculap, Inc.10
Davol, Inc.10
Depuy Intl., Ltd.10
Downs Surgical , Ltd.10
Dsp Worldwide10
Exsurco Medical01
Mattioli Engineering, Srl10
DateFirm and productCodeLinked 510(k)
Dec 15, 2025Zimmer Surgical Inc
Zimmer Dermatome AN, Model/Catalog Number: 88710100
Open, Classified
GFDNone listed
Dec 15, 2025Zimmer Surgical Inc
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Open, Classified
GFDNone listed
Oct 6, 2023Zimmer 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
GFDNone listed
Sep 12, 2020Integra 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
GFDNone listed
Sep 12, 2020Integra 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
GFDNone listed
Sep 12, 2020Integra 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
GFDNone listed
Jun 8, 2018Zimmer Surgical Inc
Zimmer Dermatone AN, Model No. 88710100
Terminated
GFDNone listed
Apr 17, 2018Exsurco Medical
Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
Terminated
GFDNone listed
Nov 5, 2016Zimmer 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
GFDNone listed
Aug 4, 2016Zimmer 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
GFDNone listed
Aug 4, 2016Zimmer 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
GFDNone listed
Aug 4, 2016Zimmer 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
GFDNone listed
Aug 4, 2016Zimmer 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
GFDNone listed
Aug 4, 2016Zimmer 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
GFDNone listed
Aug 4, 2016Zimmer 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
GFDNone listed
Aug 4, 2016Zimmer 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
GFDNone listed
Jan 7, 2015KCI 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
GFDNone listed
Sep 29, 2014KCI USA, Inc.
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Terminated
GFDNone listed
Jun 5, 2013Zimmer 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
GFDNone listed
Jun 5, 2013Zimmer 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
GFDNone listed
Jun 5, 2013Zimmer 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
GFDNone listed
May 20, 2011Integra 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
GFDNone listed

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