MDA

Product Code: MDA


Products Classified as MDA

5742Elastomer, Silicone, For Scar ManagementSilicone Sheeting.

Total Product Life Cycle (TPLC) Devices

5742Elastomer, Silicone, For Scar ManagementSilicone Sheeting.

Pre-market Notifications for MDA

K112131NEODYNE DRESSINGNEODYNE BIOSCIENCES, INC.
K111733CORELEADER SCAR-DIMMERCORELEADER BIOTECH CO., LTD.
K083718BEAU RX SCAR CARE GELBEAU RX SOLUTIONS, LLC.
K053481KELO-COTE SPRAYADVANCED BIO-TECHNOLOGIES, INC.
K041704NEWGEL AND NEWGEL PLUS ENEWMEDICAL TECHNOLOGY, INC.
K040307HANSON SCAR ADEHANSON MEDICAL, INC.
K024160NEOSPORIN SCAR SOLUTIONWARNER-LAMBERT CO.
K024057CURAD SCAR THERAPYBEIERSDORF, INC.
K023678DIMISIL SCAR GELAESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
K014036MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.MEDTRADE PRODUCTS LTD.
K013732GELZONEIMPLANTECH ASSOCIATES, INC.
K010675ENSIL FABRICGOTTFRIED MEDICAL, INC.
K010245ACTIVHEAL SCAR MANAGEMENT DRESSINGADVANCED MEDICAL SOLUTIONS LTD.
K003948EPI-DERM SILICONE GEL SHEETINGBIODERMIS CORP.
K002488KELO-COTE TOPICAL GELADVANCED BIO-TECHNOLOGIES, INC.

Global Unique Device Identification Database

00385640033367Elastomer, Silicone, For Scar Management
00385640033350Elastomer, Silicone, For Scar Management
00385640033343Elastomer, Silicone, For Scar Management
00385640033336Elastomer, Silicone, For Scar Management
00385640033329Elastomer, Silicone, For Scar Management
00385640000116Elastomer, Silicone, For Scar Management
00385640000109Elastomer, Silicone, For Scar Management
00372380000032Elastomer, Silicone, For Scar Management
00372380000025Elastomer, Silicone, For Scar Management
00372380000018Elastomer, Silicone, For Scar Management
06936943403100Elastomer, Silicone, For Scar Management
06936943403063Elastomer, Silicone, For Scar Management
06936943403070Elastomer, Silicone, For Scar Management
EBESSS4506W0Elastomer, Silicone, For Scar Management
EBESSS4506C0Elastomer, Silicone, For Scar Management

Maude Adverse Events

SILAGEN ABDOMINAL STRIPNEWMEDICAL TECHNOLOGY, INC.2020-01-30
MEPIFORMMOLNLYCKE2019-11-15
EMBRACE SCAR THERAPYNEODYNE BIOSCIENCES, INC.2019-11-01
CICA CARE 6X12CM CTN 1SMITH & NEPHEW MEDICAL LTD.2019-08-06
SCAR AWAY SILICONE SCAR GELL. PERRIGO COMPANY2019-05-23
CICA-CARE 15CM X 12CM CTN 1SMITH & NEPHEW MEDICAL LTD.2019-03-12
CICA CARE 6X12CM CTN 5SMITH & NEPHEW MEDICAL LTD.2018-12-10
SKIMATIX ULTRABAUSCH + LOMB2018-09-28
CICA-CARE 15CM X 12CM CTN 1SMITH & NEPHEW MEDICAL LTD.2017-07-19
UNKNOWN CICA CARESMITH & NEPHEW MEDICAL LTD.2017-05-16
RECEDO TOPICAL GELEXELTIS2017-03-30
SCARAWAY SIL PATCH 1.5 X 3 INBIO MED SCIENCES, INC2016-12-08
OLEEVA FABRIC SOLD AS SCARAWAY SIL SHEET 1.5X7 IN 12'SBIO MED SCIENCES, INC.2016-11-18
SCARAWAY SIL SHEET 1.5X7 IN 12'SBIO MED SCIENCES, INC.2016-11-14
CICA CARE 6X12CM CTN 1SMITH & NEPHEW MEDICAL LTD.2016-10-03
CICA-CARE 15CM X 12CM CTN 1SMITH & NEPHEW MEDICAL LTD.2016-09-06
CICA CARESMITH & NEPHEW MEDICAL (SUZHOU) LIMITED2015-07-03
CICA CARE 6X12CM CTN 3SMITH & NEPHEW MEDICAL LTD.2015-07-02
OTOFORM KNORTH COAST MEDICAL, INC.2014-05-15
SILASTIC SHEETINGDOW CORNING2013-08-23
KELO-COTE2013-04-12
NEOSPORIN SCAR SOLUTIONPFIZER INC2007-05-23
NEOSPORIN SCAR SOLUTIONPFIZER INC2007-05-23
NEOSPORIN SCAR SOLUTIONJOHNSON & JOHNSON GROUP OF CONSUMER COS.2007-02-28
NEOSPORIN SCAR SOLUTIONPFIZER INC.2006-11-21
NEOSPORIN SCAR SHEETSPFIZER, INC.2006-08-29
NEOSPORIN SCAR SHEETSPFIZER INC.2005-10-19
DIAMOND TOUCH SILICONE SHEETINGGENZYME BIOSURGERY A DIV OF GE2001-06-25
MMC SILICONE GEL SHEETINGCUI CORPORATION1998-02-23

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