Dressing, Wound, Hydrogel Without Drug And/Or Biologic

FDA product code NAE · 29 cleared devices

Class 1 General, Plastic Surgery

Regulation: 21 CFR 878.4022
Review panel: SU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-12-18 – 2009-01-08

NAE 2009-01-08

MODIFICATION TO ZENIEVA

Applicant River'S Edge Pharmaceuticals, LLC

K number K083721

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NAE 2008-10-23

MODIFICATION TO ZENIEVA

Applicant Gorbec Pharmaceutical Services, Inc.

K number K082865

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NAE 2008-07-23

ZENIEVA

Applicant Gorbec Pharmaceutical Services, Inc.

K number K073246

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NAE 1999-09-17

GILTECH PLUS HYDROGEL SKIN DRESSING

Applicant Giltech Plus, Inc.

K number K992094

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NAE 1999-06-28

DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING

Applicant Dermaphylyx, Inc.

K number K991061

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NAE 1997-08-21

AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES

Applicant Ludlow Technical Products

K number K972646

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NAE 1997-07-29

COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)

Applicant Coloplast Corp.

K number K971597

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NAE 1996-08-02

HYDROGEL SKIN DRESSING

Applicant North American Sterilization & Packaging Co.

K number K962352

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NAE 1995-08-23

AQUAFLO HYDROGEL WOUND DRESSING & PACKER

Applicant Sherwood Medical Co.

K number K952945

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NAE 1995-06-21

BIODERM MEDICAL HYDROGEL ISLAND DRESSING

Applicant Bioderm, Inc.

K number K951166

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NAE 1995-03-24

CURAGEL HYDROGEL WOUND DRESSING

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K950412

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NAE 1995-03-01

BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS

Applicant Brady Medical Products Co.

K number K945832

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NAE 1994-06-29

INTRASITE

Applicant Smith & Nephew United, Inc.

K number K942748

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NAE 1994-05-04

BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING

Applicant Brady Medical Products Co.

K number K941019

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NAE 1994-02-15

BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING

Applicant Brady Medical Products Co.

K number K935848

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NAE 1994-02-15

ALLEVYN ISLAND WOUND DRESSING

Applicant Smith & Nephew United, Inc.

K number K935705

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NAE 1994-02-15

NDM HYDROGAUZE WOUND DRESSING

Applicant Ndm Acquisition Corp.

K number K934601

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NAE 1994-02-09

NU-GEL ISLAND WOUND DRESSING

Applicant Johnson & Johnson Medical, Inc.

K number K932336

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NAE 1993-12-10

DUODERM HYDROCOLLOID GEL

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K931618

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NAE 1993-07-13

INTRASITE GEL

Applicant Smith & Nephew United, Inc.

K number K926508

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NAE 1993-05-12

CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI

Applicant Ndm Corp.

K number K926202

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NAE 1992-11-23

TRANSORB(TM) ULCER & WOUND DRESSING

Applicant Brady Medical Products Co.

K number K922666

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NAE 1992-05-28

PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH

Applicant Medtronic Vascular

K number K915359

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NAE 1992-05-28

PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH

Applicant Medtronic Vascular

K number K915357

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NAE 1992-04-21

CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION

Applicant New Dimensions IN Medicine, Inc.

K number K920677

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NAE 1992-04-21

DEROYAL HYDROGEL DRESSING

Applicant Deroyal Industries, Inc.

K number K915182

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NAE 1991-10-23

CLEARSITE(R) STERILE WOUND CARE DRESSING

Applicant Ndm Acquisition Corp.

K number K914207

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NAE 1981-09-11

IP-758 BURN WOUND DRESSING

Applicant Exopack

K number K810902

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NAE 1980-12-18

LOMATUELL OINTMENT DRESSING

Applicant Secol Co.

K number K802793

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