ClearanceBrief
Panels › General, Plastic Surgery › Product code KKX · Class 2

Drape, Surgical, Antimicrobial

Regulation 878.4370

0510(k)s in 12 months (450 all time)
3recalls in 12 months (92 all time)
57recalls that name a 510(k)
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Top companies in KKX

DateFirm and productCodeLinked 510(k)
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the c
Terminated
KKXK050322
Dec 16, 2014Customed, Inc
Fanfold Drape, Catalog number 900-633. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXNone listed
Dec 16, 2014Customed, Inc
O.R. Towels, Catalog number 900-629. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXNone listed
Dec 16, 2014Customed, Inc
Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXNone listed
Dec 16, 2014Customed, Inc
Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXNone listed
Dec 16, 2014Customed, Inc
Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXNone listed
Dec 16, 2014Customed, Inc
Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXNone listed
Dec 16, 2014Customed, Inc
Utility Drape End Product, Catalog number 900-582. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXNone listed
Aug 29, 2014Customed, Inc
Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X 24 L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag
Terminated
KKXNone listed
Aug 29, 2014Customed, Inc
FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Terminated
KKXNone listed
Aug 29, 2014Customed, Inc
O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Terminated
KKXNone listed
Feb 12, 2014Custom Medical Specialties, Inc.
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. P
Terminated
KKXK882724
Feb 10, 2014Ecolab Inc
Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
Terminated
KKXK882724
Feb 10, 2014Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Terminated
KKXK882724
Feb 10, 2014Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Terminated
KKXK882724
Feb 10, 2014Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Terminated
KKXK882724
Feb 10, 2014Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Terminated
KKXK882724
Feb 10, 2014Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
Terminated
KKXK882724
Aug 21, 2013Blue Belt Technologies MN
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of proc
Terminated
KKXK050322
Nov 7, 2012Kimberly-Clark Corporation
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of micro
Terminated
KKXK103406
K842115
Sep 20, 2012Kimberly-Clark Corporation
ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patien
Terminated
KKXNone listed
Jul 21, 2011Kimberly-Clark Corporation
Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape.
Terminated
KKXNone listed
Dec 10, 2010Microtek Medical, Inc.
Microtek Medical, Inc., Microscope Drape for Zeiss Standard Model/Catalog Number: 70890655 Product Description: The Microtek Medical, Inc., Microscope Drape for Zeiss Standard is intended is to prot
Terminated
KKXK050322
Jul 23, 2008OEC Medical Systems, Inc
Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.
Terminated
KKXNone listed
Oct 21, 2006Cardinal Health
Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico; catalog #9158N
Terminated
KKXNone listed
Oct 21, 2006Cardinal Health
Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico The cardiovascular drapes were packagaged under the followin
Terminated
KKXNone listed
Jun 17, 2006Abbott Spine
Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.
Terminated
KKXNone listed
Sep 21, 2005North Coast Medi-Tek Inc
Ultrasound probe cover, sterile. Catalog No. 910811.
Terminated
KKXK050322
Sep 29, 2004Deroyal Surgical -Rose Hill
Stockinette, Double Ply, Econo Weave, EZ Roll, 6 X 60'', 8 X 60'', Ref#9991-60, #9993-60
Terminated
KKXK030365
Sep 29, 2004Deroyal Surgical -Rose Hill
Stockinette, Double Ply, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Ref #9984-54, #9984-54, #9985-60, #9986-72, #9987-48, #9988-60, #9988-72
Terminated
KKXK030365
Sep 29, 2004Deroyal Surgical -Rose Hill
Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48''
Terminated
KKXK030365
Sep 29, 2004Deroyal Surgical -Rose Hill
Stockinette, Single Ply, Standard Weave, 8 X 72'' and 10 X 48'', Ref #9508-72, #9510-48, #9510-48, #9510-60
Terminated
KKXK030365
Sep 29, 2004Deroyal Surgical -Rose Hill
Stockinette, Single Ply Econo Weave, 8 X 72'', Ref #9999-72.
Terminated
KKXK030365
Sep 29, 2004Deroyal Surgical -Rose Hill
Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large, 16'' X 48'', Ref #9978-16
Terminated
KKXK030365
Jul 22, 2004Medikmark, Incorporated
Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case: a) Medikmark inc. Staple R
Terminated
KKXK920340
Jul 22, 2004Medikmark, Incorporated
MediChoice Skin Staple Remover, reorder no. SSR 1001; a sterile Rx convenience kit containing a skin staple remover, a PVP prep pad and a 3 x 3 gauze sponge; 50 kits per case; Made for Owens & Minor
Terminated
KKXK920340
Jul 22, 2004Medikmark, Incorporated
Staple Removal Tray/Set/Kit; a sterile Rx convenience kit containing a staple remover instrument, an alcohol prep pad, a PVP prep pad and a gauze sponge. Theses kits were marketed under the following
Terminated
KKXK920340
Nov 13, 2003Medline Industries Inc
Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486
Terminated
KKXK962205
Aug 14, 2003Molnlycke Health Care Inc
Barrier Hip Sheet with Side Pockets
Terminated
KKXK780282
May 16, 20033m Health Care
3M Ioban 2 Antimicrobial Incise Drapes, Model 6651EZ
Terminated
KKXNone listed
May 16, 20033m Health Care
3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ
Terminated
KKXK801550
Feb 25, 2003Allegiance Healthcare Corp.
Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; individually packaged drapes, 20 packages per case
Terminated
KKXK002419

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