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)
Top companies in KKX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Dec 16, 2014 | Customed, 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 |
KKX | None listed |
| Dec 16, 2014 | Customed, 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 |
KKX | None listed |
| Dec 16, 2014 | Customed, 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 |
KKX | None listed |
| Dec 16, 2014 | Customed, 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 |
KKX | None listed |
| Dec 16, 2014 | Customed, 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 |
KKX | None listed |
| Dec 16, 2014 | Customed, 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 |
KKX | None listed |
| Dec 16, 2014 | Customed, 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 |
KKX | None listed |
| Aug 29, 2014 | Customed, 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 |
KKX | None listed |
| Aug 29, 2014 | Customed, 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 |
KKX | None listed |
| Aug 29, 2014 | Customed, 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 |
KKX | None listed |
| Feb 12, 2014 | Custom 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 |
KKX | K882724 |
| Feb 10, 2014 | Ecolab 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 |
KKX | K882724 |
| Feb 10, 2014 | Ecolab 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 |
KKX | K882724 |
| Feb 10, 2014 | Ecolab 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 |
KKX | K882724 |
| Feb 10, 2014 | Ecolab 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 |
KKX | K882724 |
| Feb 10, 2014 | Ecolab 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 |
KKX | K882724 |
| Feb 10, 2014 | Ecolab 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 |
KKX | K882724 |
| Aug 21, 2013 | Blue 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 |
KKX | K050322 |
| Nov 7, 2012 | Kimberly-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 |
KKX | K103406 K842115 |
| Sep 20, 2012 | Kimberly-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 |
KKX | None listed |
| Jul 21, 2011 | Kimberly-Clark Corporation Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable,
Surgical drape. Terminated |
KKX | None listed |
| Dec 10, 2010 | Microtek 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 |
KKX | K050322 |
| Jul 23, 2008 | OEC Medical Systems, Inc Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10. Terminated |
KKX | None listed |
| Oct 21, 2006 | Cardinal 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 |
KKX | None listed |
| Oct 21, 2006 | Cardinal 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 |
KKX | None listed |
| Jun 17, 2006 | Abbott Spine Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''. Terminated |
KKX | None listed |
| Sep 21, 2005 | North Coast Medi-Tek Inc Ultrasound probe cover, sterile. Catalog No. 910811. Terminated |
KKX | K050322 |
| Sep 29, 2004 | Deroyal Surgical -Rose Hill Stockinette, Double Ply, Econo Weave, EZ Roll, 6 X 60'', 8 X 60'', Ref#9991-60, #9993-60 Terminated |
KKX | K030365 |
| Sep 29, 2004 | Deroyal 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 |
KKX | K030365 |
| Sep 29, 2004 | Deroyal 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 |
KKX | K030365 |
| Sep 29, 2004 | Deroyal 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 |
KKX | K030365 |
| Sep 29, 2004 | Deroyal Surgical -Rose Hill Stockinette, Single Ply Econo Weave, 8 X 72'', Ref #9999-72. Terminated |
KKX | K030365 |
| Sep 29, 2004 | Deroyal 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 |
KKX | K030365 |
| Jul 22, 2004 | Medikmark, 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 |
KKX | K920340 |
| Jul 22, 2004 | Medikmark, 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 |
KKX | K920340 |
| Jul 22, 2004 | Medikmark, 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 |
KKX | K920340 |
| Nov 13, 2003 | Medline 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 |
KKX | K962205 |
| Aug 14, 2003 | Molnlycke Health Care Inc Barrier Hip Sheet with Side Pockets Terminated |
KKX | K780282 |
| May 16, 2003 | 3m Health Care 3M Ioban 2 Antimicrobial Incise Drapes, Model 6651EZ Terminated |
KKX | None listed |
| May 16, 2003 | 3m Health Care 3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ Terminated |
KKX | K801550 |
| Feb 25, 2003 | Allegiance 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 |
KKX | K002419 |
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