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Panels › General, Plastic Surgery › Product code GDX · Class 1

Scalpel, One-Piece

Regulation 878.4800

0510(k)s in 12 months (26 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
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Top companies in GDX

Company510(k)sRecalls
Southmedic, Inc.04
Abco Dealers, Inc.10
Applied Medical Technologies10
Artiberia10
Ascep, Inc.10
Buckman Co., Inc.10
CooperVision, Inc.10
Depuy, Inc.10
Diverse Technologies, Inc.10
Icn Pharmaceuticals, Inc.10
DateFirm and productCodeLinked 510(k)
Nov 6, 2017Southmedic, Inc.
Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
Terminated		 GDXNone listed
Sep 21, 2015Zien Medical Technologies, Inc
PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
Terminated		 GDXNone listed
Feb 27, 2013Myco Medical Supplies Inc
Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
Terminated		 GDXNone listed
Jan 31, 2011Southmedic, Inc.
Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Ba
Terminated		 GDXNone listed
Jan 31, 2011Southmedic, Inc.
Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0611, Size #11, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Ba
Terminated		 GDXNone listed
Jan 31, 2011Southmedic, Inc.
Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0610, Size #10, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Ba
Terminated		 GDXNone listed

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