Panels › General Hospital › Product code OXQ · Class 1
Dressing Change Tray
Regulation 880.5075
0510(k)s in 12 months (0 all time)
14recalls in 12 months (69 all time)
6recalls that name a 510(k)
Top companies in OXQ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
CMH CENTRAL LINE DRESSING CHANGE KIT
EBSI1705A
CVC/PICC/MIDLINE DRESSING CHANGE KIT
EBSI1057A
DIALYSIS DRESSING CHANGE
EBSI1498
EBSI CVC DRESSING CHANGE KIT
EBSI1585
PIC Open, Classified |
OXQ | None listed |
| Jun 12, 2026 | Medline Industries, LP Centurion convenience kits:
CENTRAL LINE DRESSING SV43 FCP
DYNDC2356B
DIALYSIS CATHETER MAINTENANCE KIT
DT17570
DIALYSIS DRESSING CHANGE KIT
DT21370B
DRESSING CHANGE TRAY - GOLD
DT21115B
PORT DRE Open, Classified |
OXQ | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kit:
KIT: DRESSING CHANGE PED
DYNDC3359 Open, Classified |
OXQ | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) LVAD DRIVELINE TRAY, Model Number: DM1035;
2) LVAD DRIVELINE TRAY, Model Number: DM1035A;
3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A Open, Classified |
OXQ | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:
1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion);
2. LONG TERM/INPATIEN Open, Classified |
OXQ | None listed |
| Apr 22, 2026 | LSL Healthcare Inc. LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H Open, Classified |
OXQ | None listed |
| Apr 22, 2026 | LSL Healthcare Inc. LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J Open, Classified |
OXQ | None listed |
| Apr 22, 2026 | LSL Healthcare Inc. LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H Open, Classified |
OXQ | None listed |
| Feb 24, 2026 | Medline Industries, LP Convenience kits containing Tego Connectors
Medline DIALYSIS DRSNG CHNG
SKU DYNDC3167 Open, Classified |
OXQ | None listed |
| Feb 24, 2026 | Medline Industries, LP Convenience kits containing Tego Connectors:
Medline DIALYSIS DRESSING CHANGE
SKU EBSI1498
Medline DIALYSIS DRESSING CHANGE KIT
SKU EBSI1107
EBSI1596
EBSI1781
EBSI1812
Centurion DIALYSIS/PHERESUS C Open, Classified |
OXQ | None listed |
| Feb 20, 2026 | Medline Industries, LP Medline Convenience Kits:
1) NAIL KIT, Model Number: DYKM1528 Open, Classified |
OXQ | K112666 |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) LVAD DRIVELINE TRAY, Model Number: DM1035A;
2) LVAD DRIVELINE TRAY, Model Number: DM1035;
3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A Open, Classified |
OXQ | None listed |
| Feb 9, 2026 | Medline Industries, LP Medline medical convenience kits packaged as:
) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C;
2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A;
3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; Open, Classified |
OXQ | None listed |
| Jan 28, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as:
1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880;
2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A. Open, Classified |
OXQ | None listed |
| Jan 28, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray Open, Classified |
OXQ | None listed |
| Jan 22, 2025 | Trinity Sterile, Inc. Brand Name: Tacy Medical, Inc.
Product Name: Dressing Change Tray CS/20
Model/Catalog Number: TM6180CP
Software Version: N/A
Product Description: Dressing change tray, case of 20, lot #600032, 50 case Open, Classified |
OXQ | None listed |
| Jan 22, 2025 | Trinity Sterile, Inc. Brand Name: Wolf-Pak
Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30
Model/Catalog Number: DC5090LF
Software Version: N/A
Product Description: Dressing change kit, case of 30, Open, Classified |
OXQ | None listed |
| Jan 22, 2025 | Trinity Sterile, Inc. Brand Name: Wolf-Pak
Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30
Model/Catalog Number: DC3080LF
Software Version: N/A
Product Description: Open, Classified |
OXQ | None listed |
| Jan 22, 2025 | Trinity Sterile, Inc. Brand Name: Wolf-Pak
Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30
Model/Catalog Number: DC3077LF
Software Version: N/A
Product Description: Dressing Open, Classified |
OXQ | None listed |
| Jan 22, 2025 | Trinity Sterile, Inc. Brand Name: IMed Products
Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD
Model/Catalog Number: IM46062
Software Version: N/A
Product Description: Dressing change kit, case of 30, lo Open, Classified |
OXQ | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit Open, Classified |
OXQ | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;
2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;
3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; Open, Classified |
OXQ | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) CIRCUMCISION TRAY, Pack Number CIT6715;
2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920;
3) PORT DRESSING CHANGE TRAY, Pack Number DT18415;
4) UC Open, Classified |
OXQ | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure kits labeled as:
1) BONE MARROW TRAY, Pack Number SPEC0255;
2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262;
3) FINE LACERATION KIT, Pack Number SUT17215;
4) INFECTION DRIVELINE Open, Classified |
OXQ | None listed |
| Mar 29, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion PICC LINE SECUREMENT KIT, Product Code IVS565 Open, Classified |
OXQ | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion Kits, trays, and packs labeled as follows:
a) A C DAILY WET KIT, REF DM405A;
b) BWH DAILY DRIVELINE MGMT KIT, REF DM640;
c) DAILY DRIVELINE MGMT SYSTEM, REF DM600;
d) DAILY MAINTENANCE Open, Classified |
OXQ | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits, trays, and packs labeled as follows:
a) CENTRAL LINE TRAY, REF CVI4705;
b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700;
c) DRESSING CHANGE TRAY, REF DYNDC3131A;
d) DRIVELINE MAINTEN Open, Classified |
OXQ | None listed |
| Jan 3, 2024 | ROi CPS LLC Regard Dressing change kit, Item Number 800026006 Terminated |
OXQ | None listed |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. CVC INFANT INSERTION PACK, Model Number: CVI4770A;
b. INSERTION BUNDLE, Model Numb Open, Classified |
OXQ | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) CVC INFANT INSERTION PACK, Model Number CVI4770A;
b) INSERTION BUNDLE, Model Number DT21275;
c) VA MAINTENANC Open, Classified |
OXQ | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
UNIVERSAL DRESSING & PPE KIT, Model Number DT22065 Open, Classified |
OXQ | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as:
a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400;
b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT2 Open, Classified |
OXQ | None listed |
| Jan 25, 2023 | MEDLINE INDUSTRIES, LP - Northfield CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760 Open, Classified |
OXQ | None listed |
| Jun 29, 2022 | Trinity Sterile, Inc. Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30
Ref: DC5090LF Terminated |
OXQ | None listed |
| Jun 29, 2022 | Trinity Sterile, Inc. Wolf Pak Premium Dressing Change Kit with Statlock CS/30
Ref: DC5040LF Terminated |
OXQ | None listed |
| Jun 29, 2022 | Trinity Sterile, Inc. Wolf-Pak Premium Dressing Kit with GuardVA Cs/30
Ref: DC5030LF Terminated |
OXQ | None listed |
| Jun 29, 2022 | Trinity Sterile, Inc. Sklar Instruments IV Cath Dressing Tray Cs/25
Re-Order Number: 96-1708 Terminated |
OXQ | None listed |
| May 10, 2022 | Stradis Healthcare VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS Open, Classified |
OXQ | None listed |
| Mar 3, 2022 | DeRoyal Industries Inc DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection. Terminated |
OXQ | None listed |
| Apr 15, 2021 | Vygon U.S.A. Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS. Open, Classified |
OXQ | None listed |
| Mar 26, 2021 | ROi CPS LLC Regard Dressing Change Tray Terminated |
OXQ | None listed |
| Feb 23, 2021 | Trinity Sterile, Inc. Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing).
Product Number: TRIO0000l Terminated |
OXQ | None listed |
| Aug 12, 2020 | Medline Industries Inc Central Line Dressing Change Tray Terminated |
OXQ | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Dressing Tray
M101156A DRESSING TRAY
M101167A DRESSING TRAY
M101168A DRESSING TRAY
M101170A MAJOR DRESSING TRAY
M101170A MAJOR DRESSING TRAY
M101170A MAJOR DRESSING TRAY
M101170A MAJOR DRES Terminated |
OXQ | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-
LC145 STERILE NICU LINE CHANGE KIT Terminated |
OXQ | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-
HT5555A HYPERALIMENTATION & DRSG CHG TRAY Terminated |
OXQ | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Driveline System Kit
TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM Terminated |
OXQ | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-LVAD Kits
DM1005 DAILY LVAD MAINTENANCE KIT
DM280A LVAD MANAGEMENT SYSTEM 2-7
DM320 PERCUTANEOUS LEAD MANAGEMENT KIT
DM380 DAILY LVAD KIT MORRISTOWN MEDICAL
DM405A ADVOCATE CHRIST DAILY WET Terminated |
OXQ | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- DRESSING CHANGE KIT
BSICVC1005A CVC DRESSING CHANGE KIT NICU
BSIPICC1002A PICC DRESSING CHANGE KIT NICU
BSIPICC1003A PICC DRESSING CHANGE KIT Terminated |
OXQ | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Dressing Change Kits
DYNDC1182B PICC INSERTION TRAY
DYNDC1251D CENTRAL LINE TRAY
DYNDC1251D CENTRAL LINE TRAY
DYNDC1586C CENTRAL LINE DRESSING NGE TRAY
DYNDC1597A CVC DRESSING CHANGE TRAY
D Terminated |
OXQ | None listed |
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