Company ยท US
Centurion Medical Products Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2022. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
286recalls (0 in 12 months)
40recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LRS | I.V. Start Kit | 96 |
| LRP | Tray, Surgical | 48 |
| MCY | Wound Dressing Kit | 39 |
| OXQ | Dressing Change Tray | 26 |
| OES | Cardiac Catheterization Kit | 15 |
| OGR | Ear, Nose, And Throat Surgical Tray | 5 |
| OHG | Circumcision Tray | 5 |
| LRO | General Surgery Tray | 4 |
| BTR | Tube, Tracheal (W/Wo Connector) | 3 |
| FKG | Tray, Start/Stop (Including Contents), Dialysis | 3 |
| MLT | Pelvic Exam Kit | 3 |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 3 |
| OJU | Skin Prep Tray | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 2 |
| FPA | Set, Administration, Intravascular | 2 |
| HFX | Clamp, Circumcision | 2 |
| KYW | Container, Liquid Medication, Graduated | 2 |
| LRQ | Tracheostomy And Nasal Suctioning Kit | 2 |
| MCZ | Suture Removal Kit | 2 |
| OFA | Cardiovascular Surgical Instruments Tray | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2022 | K210548 | Medline Integrated Arterial Catheter Centurion Medical Products | DQX |
| Nov 22, 2016 | K161408 | Compass Cast and MAP Centurion Medical Products Corporation | DRS |
| Jun 23, 2011 | K103562 | CENTURION PRESSURE INJECTABLE EXTENSION SET Centurion Medical Products Corporation | FPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-
P151659 BIOPSY TRAY
P243133 LATEX TUBING PACK
P243133 LATEX TUBING PACK
P243133 LATEX TUBING PACK
P261569 PACK BIOPSY
P392929 BMT-LACERATION PACK
P429589A TRAY BONE MARRO ASC LTX SAFE
P734 Terminated |
PXP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-
UVT1045 UMBILICAL ARTERY TRAY
UVT1055 UVC KIT
UVT1065 UMBILICAL VESSEL CATHETER TRAY
UVT170 UMBILICAL VESSEL TRAY W/O CATHETER
UVT280 UMBILICAL ARTERY TRAY
UVT460 UMBILICAL CATHETER TRAY
U Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-
PT225 PAIN MANAGEMENT TRAY Terminated |
LRO | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Skin Prep Trays
SP1180 DRY PREP SET
SP200 SKIN SCRUB TRAY
SP415 STERILE GAUZE SPONGE Terminated |
OJU | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- ENT
SNUF3 SNUFFER KIT Y Terminated |
OGR | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Skin Prep Kits
SB1280 SKIN SCRUB KIT
SB1525 VAGINAL PREP TRAY Terminated |
OJU | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Nasal Speculum
NSP500ST STERILE NASAL SPECULUM Terminated |
OGR | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-
OR2020 BASIN SET Terminated |
LRP | 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- Port Draw Kit
KNV30 PORT DRAW KIT Terminated |
OIB | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion
IVS3505 ULTRASOUND GUIDED PIV KIT Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Irrigation Kit
IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Infant Feeding Kit
IFK840 INFANT FEEDING KIT (8 FR X 40 IN) Terminated |
PRR | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-
I86625 DEBRIDEMENT TRAY Terminated |
LRP | 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-Pitcher Kit
GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090
GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990 Terminated |
KYW | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Medicine Cup
GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE Terminated |
KYW | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Trays
EBSI1021 VALVE CHANGE KIT- DOUBLE Terminated |
KCZ | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Trays
DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL
DYNJ1000 NEWBORN CIRCUMCISION TRAY Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Suture Tray
DYNDR1210A SUTURING TRAY Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Skin Prep Tray
DYNDP1015 SKIN PREP TRAY Terminated |
OJU | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Drive 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 |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Vaginal Speculum
VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT Terminated |
MLT | 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- Biopsy Tray
TRIBT170 BIOPSY TRAY Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Trach Kits
TC6282G TRACHEOSTOMY CARE TRAY
TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY
TC7370 TRACHEOSTOMY KIT
TC7450 DISPOSABLE TRACH TRAY Terminated |
LRQ | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Uterine Sound
67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790 Terminated |
HHM | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Pathology Container
1150ST STERILE GRADUATED CONTAINER, 32 OZ.
17070 AI OR CARDIAC STERILE KIT
3703ST STERILE PATHOLOGY CONTAINER
3706ST STERILE CONTAINER 165 OZ. Terminated |
FMH | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Trach Kits
TC6282G TRACHEOSTOMY CARE TRAY
TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY
TC7370 TRACHEOSTOMY KIT
TC7450 DISPOSABLE TRACH TRAY Terminated |
LRQ | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Incision /Drainage Tray
ID1235A ESKENAZI INCISION & DRAINAGE TRAY
ID1525 INCISION & DRAINAGE TRAY
ID1670 I&D TRAY
ID1715 INCISION & DRAINAGE TRAY
ID1765 ER I&D PACK
ID1765 ER I&D PACK
ID1835 Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Surgical trays
DYNJ04079Z CIRCUMCISION TRAY STERILE
DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL
DYNJ1000 NEWBORN CIRCUMCISION TRAY Terminated |
OHG | 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-BIOPSY TRAY
BT205A MINOR SET UP BIOPSY TRAY
BT345A HH PACK BIOPSY Terminated |
LRP | 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-BLOOD CULTURE COLLECTION KIT
BP115 BLOOD CULTURE COLLECTION KIT Terminated |
OIB | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Umbilical Vessel
UPC175 UMBILICAL VESSEL CATH. INSERTION
UPC175 UMBILICAL VESSEL CATH. INSERTION Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Umbilical Trays
UVT1045 UMBILICAL ARTERY TRAY
UVT1055 UVC KIT
UVT1065 UMBILICAL VESSEL CATHETER TRAY
UVT170 UMBILICAL VESSEL TRAY W/O CATHETER
UVT280 UMBILICAL ARTERY TRAY
UVT460 UMBILICAL Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Suture Trays
SUT10140 SUTURE TRAY
SUT10290 LACERATION TRAY
SUT10705 SUTURING TRAY
SUT10770 DEBRIDEMENT/SUTURE SET
SUT10795 PORT IMPLANT SET
SUT11035 SUTURE TRAY
SUT11065 LACERATION TRAY
SUT1 Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-
SPEC0002B ARTHROGRAM TRAY
SPEC0002B ARTHROGRAM TRAY
SPEC0004C ARTHROGRAM TRAY
SPEC0071B CUSTOM BX TRAY
SPEC0076G STEREO BIOPSY PACK-LF
SPEC0122 BASIC BIOPSY TRAY
SPEC0130B BREAST BIOPSY TRA Terminated |
PXP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Pelvic
PE120 LARGE/MEDIUM PELVIC TRAY
PE2200 PELVIC EXAM TRAY
PE2200 PELVIC EXAM TRAY
PE2400 PELVIC EXAM TRAY
PE2515 SMALL GYN EXAM TRAY
PE2515 SMALL GYN EXAM TRAY
PE2610 PELVIC EXAM TRAY
PE Terminated |
MLT | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Surgical Tray
MNS10255 DELIVERY TRAY
MNS10255 DELIVERY TRAY
MNS10310 MEATOTOMY TRAY
MNS10310 MEATOTOMY TRAY
MNS10525 DELIVERY INSTRUMENT TRAY
MNS10620 PACEMAKER TRAY
MNS10820 ENT/EPISTAXIS K Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Laceration Trays
DYNDL1073 LACERATION TRAY
DYNDL1152A LACERATION TRAY
DYNDL1152A LACERATION TRAY
DYNDL1223A LACERATION TRAY
DYNDL1295B KIT,PAIN
DYNDL1436A LACERATION TRAY
DYNDL1436A LACERAT Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-General Surgery Convenience Kits
DYNDH1033B SUBCLAVIAN ON/OFF KIT
DYNDH1090A SDS PROCEDURE PACK
DYNDH1110 BIOPSY PACK
DYNDH1110 BIOPSY PACK
DYNDH1110 BIOPSY PACK
DYNDH1114 BIOPSY TRAY
DYNDH1 Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Circumcision Tray Kits
DYNDF1078C CIRCUMCISION TRAY
DYNDF1082 CIRCUMCISION TRAY
DYNDF1082 CIRCUMCISION TRAY
DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP
DYNDF1093C UNIVERSAL CIR Terminated |
OHG | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Pelvic Exam Kits
DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090
DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790 Terminated |
MLT | 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 |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-_General Surgery Trays
DYNDA1127A RADIOLOGY CUT DOWN TRAY #1
DYNDA1178 ICIO TRAY
DYNDA1183 AUXILARY TOWEL PACK
DYNDA1223 CUSTOM PREP CUP KIT
DYNDA1223 CUSTOM PREP CUP KIT
DYNDA1246A CIRCUMCI Terminated |
LRP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Dressing Change Tray
DT10290S CENTRAL LINE PREPARATION PACK
DT10290S CENTRAL LINE PREPARATION PACK
DT10415 PICC INSERTION TRAY
DT10495 PICC INSERTION TRAY
DT10525 CENTRAL LINE INSERTION DRA Terminated |
OXQ | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion Dental Kits
DH775 PREMIUM DENTAL EXAM TRAY
DYKA1169B DENTAL KIT Y 2019011690 Terminated |
OFX | None listed |
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