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)
May 7, 2026Medline Industries, LP
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
Open, Classified
KKXK962205
Apr 17, 2026Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Open, Classified
KKXK020393
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
Open, Classified
KKXNone listed
Sep 4, 2025O&M HALYARD INC
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Open, Classified
KKXK083234
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239
Open, Classified
KKXNone listed
Jan 17, 2025O&M HALYARD, INC.
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Open, Classified
KKXK083234
Oct 23, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
Open, Classified
KKXNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PAC
Open, Classified
KKXK962205
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number: DYNJ42065B
Open, Classified
KKXNone listed
Feb 10, 2023MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Open, Classified
KKXK962205
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
Open, Classified
KKXNone listed
Dec 20, 2019Arrow International Inc
Arrow Maximal Barrier Drape ASK-00002-1A
Terminated
KKXK850199
Apr 11, 2018Arrow International Inc
Clear Fenestrated Drape with Adhesive; Product Code: CD-00001
Terminated
KKXK964142
Apr 11, 2018Arrow International Inc
Maximal Barrier Drape; Product Codes: ASK-00002-1A
Terminated
KKXK060200
Apr 11, 2018Arrow International Inc
Maximal Barrier Drape; Product Codes: ASK-00001-1A
Terminated
KKXK964142
Jul 7, 2017Cardinal Health 200, LLC
Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials int
Terminated
KKXNone listed
Jul 7, 2017Cardinal Health 200, LLC
Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synt
Terminated
KKXNone listed
Dec 8, 2016Halyard Health, Inc
Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with
Terminated
KKXK862801
Nov 30, 2016Ecolab Inc
Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
Terminated
KKXK882724
Jul 14, 2016Ecolab Inc
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus,
Terminated
KKXNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXK902886
Apr 14, 2016Customed, Inc
Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXK902886
Apr 14, 2016Customed, Inc
Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
KKXK902886
Mar 3, 2016Volcano Corporation
Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot b
Terminated
KKXK052395
Mar 3, 2016Volcano Corporation
Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be ste
Terminated
KKXK052395
Sep 3, 2015Customed, Inc
FANFOLD DRAPE 44"X58 60/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KKXNone listed
Sep 3, 2015Customed, Inc
O.R. TOWELS 25/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KKXNone listed
Sep 3, 2015Customed, Inc
UTILITY DRAPE END PRODUCT 50PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KKXNone listed
Sep 3, 2015Customed, Inc
BASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KKXNone listed
Sep 3, 2015Customed, Inc
(1) (2) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KKXNone listed
Sep 3, 2015Customed, Inc
CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KKXNone listed
Sep 3, 2015Customed, Inc
ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KKXK902886
Sep 3, 2015Customed, Inc
MAYO STAND COVER W/CSR WRAP 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KKXNone listed
Sep 3, 2015Customed, Inc
UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KKXK902886
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various sett
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various sett
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Camera 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 throughou
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various setti
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various setti
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various setti
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various s
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Monitor 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 t
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings througho
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings t
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Camera 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
Terminated
KKXK050322
Apr 6, 2015Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Camera 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
Terminated
KKXK050322

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