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) |
|---|---|---|---|
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DRAPE PACK, Model Number: DYNJ35363A;
2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005 Open, Classified |
KKX | K962205 |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
E P DRAPE PACK-LF DYNJ0373061J Open, Classified |
KKX | K020393 |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DRAPE PACK, Model Number: DYNJ35363A;
2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005 Open, Classified |
KKX | None listed |
| Sep 4, 2025 | O&M HALYARD INC Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029
Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 Open, Classified |
KKX | K083234 |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239 Open, Classified |
KKX | None listed |
| Jan 17, 2025 | O&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 |
KKX | K083234 |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand medical procedure convenience kits, labeled as:
a) UNIVERSAL DRAPE PACK, REF DYNJ44114;
b) DRAPE PACK, REF DYNJ82663B Open, Classified |
KKX | None listed |
| Sep 6, 2024 | MEDLINE 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 |
KKX | K962205 |
| Aug 3, 2023 | MEDLINE 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 |
KKX | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as:
MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063 Open, Classified |
KKX | K962205 |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK Open, Classified |
KKX | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow Maximal Barrier Drape
ASK-00002-1A Terminated |
KKX | K850199 |
| Apr 11, 2018 | Arrow International Inc Clear Fenestrated Drape with Adhesive; Product Code: CD-00001 Terminated |
KKX | K964142 |
| Apr 11, 2018 | Arrow International Inc Maximal Barrier Drape; Product Codes: ASK-00002-1A Terminated |
KKX | K060200 |
| Apr 11, 2018 | Arrow International Inc Maximal Barrier Drape; Product Codes: ASK-00001-1A Terminated |
KKX | K964142 |
| Jul 7, 2017 | Cardinal 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 |
KKX | None listed |
| Jul 7, 2017 | Cardinal 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 |
KKX | None listed |
| Dec 8, 2016 | Halyard 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 |
KKX | K862801 |
| Nov 30, 2016 | Ecolab Inc Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only. Terminated |
KKX | K882724 |
| Jul 14, 2016 | Ecolab 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 |
KKX | None listed |
| Apr 14, 2016 | Customed, 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 |
KKX | None listed |
| Apr 14, 2016 | Customed, 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 |
KKX | None listed |
| Apr 14, 2016 | Customed, 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 |
KKX | None listed |
| Apr 14, 2016 | Customed, 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 |
KKX | K902886 |
| Apr 14, 2016 | Customed, 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 |
KKX | K902886 |
| Apr 14, 2016 | Customed, 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 |
KKX | K902886 |
| Mar 3, 2016 | Volcano 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 |
KKX | K052395 |
| Mar 3, 2016 | Volcano 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 |
KKX | K052395 |
| Sep 3, 2015 | Customed, 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 |
KKX | None listed |
| Sep 3, 2015 | Customed, 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 |
KKX | None listed |
| Sep 3, 2015 | Customed, 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 |
KKX | None listed |
| Sep 3, 2015 | Customed, 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 |
KKX | None listed |
| Sep 3, 2015 | Customed, 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 |
KKX | None listed |
| Sep 3, 2015 | Customed, 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 |
KKX | None listed |
| Sep 3, 2015 | Customed, 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 |
KKX | K902886 |
| Sep 3, 2015 | Customed, 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 |
KKX | None listed |
| Sep 3, 2015 | Customed, 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 |
KKX | K902886 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
| Apr 6, 2015 | Intuitive 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 |
KKX | K050322 |
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