Centurion Medical Products, LP
Howell, MI, US
CENTURION MEDICAL PRODUCTS, LP appears in FDA device records in Howell, MI. FDA records list 19 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 313 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Centurion Medical Products, LP carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Tri-State Hospital Supply Corp.510(k), recall
510(k) clearance history
FDA records hold 19 510(k) clearances for Centurion Medical Products, LP between 1981 and 2022. The busiest year on record is 1987, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1987 | 3 |
| 1989 | 2 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 2 |
| 1995 | 2 |
| 2008 | 2 |
| 2011 | 1 |
| 2016 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210548 | Medline Integrated Arterial Catheter | DQX | Substantially Equivalent | |
| K161408 | Compass Cast and MAP | DRS | Substantially Equivalent | |
| K103562 | CENTURION PRESSURE INJECTABLE EXTENSION SET | FPA | Substantially Equivalent | |
| K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | FMQ | Substantially Equivalent | |
| K080524 | CENTURION SORBAVIEW OTC | NAD | Substantially Equivalent | |
| K942353 | CENTURION UMBILICAL CATHETER | FOS | Substantially Equivalent | |
| K945977 | CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING | MGP | Substantially Equivalent | |
| K931748 | CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS | LJT | Unknown | |
| K935491 | CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) | HFX | Substantially Equivalent | |
| K923812 | CENTURION DISPOSABLE INSTRUMENTS | MDM | Substantially Equivalent | |
| K910906 | CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS | FPK | Substantially Equivalent | |
| K897100 | CENTURION VAGINAL SPECULUM | HIC | Substantially Equivalent | |
| K896320 | CENTURION KLEEN-NEEDLE SYSTEM | FMI | Substantially Equivalent | |
| K893647 | COPOLYESTER FILM DRESSING | KGN | Substantially Equivalent | |
| K890897 | CENTURION CIRCLAMP | HFX | Substantially Equivalent | |
| K872141 | CENTURION SPECIMEN TRAP W/CATHETER | BSY | Substantially Equivalent | |
| K872097 | INFANT FEEDING TUBE | KNT | Substantially Equivalent | |
| K872096 | INFANT FEEDING KIT/SET NASOGASTRIC FEEDING KIT | KNT | Substantially Equivalent | |
| K810375 | CENTURION STOPCOCK 3 WAY | FMG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1824619 | 1824619 | CENTURION MEDICAL PRODUCTS, LP | 301 Catrell Dr, HOWELL, MI 48843 US | 2026 | and 51 more, listed in full below |
| 3008403546 | 3008403546 | CENTURION MEDICAL PRODUCTS, LP | 100 Centurion Way, Williamston, MI 48895 US | 2026 | and 21 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ILDAdaptor, Dressing
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- KXGApplicator, Absorbent Tipped, Sterile
- ITGBandage, Cast
- GFFBur, Surgical, General & Plastic Surgery
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- FOSCatheter, Umbilical Artery
- BSYCatheters, Suction, Tracheobronchial
- HXDClamp
- HFXClamp, Circumcision
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- FMHContainer, Specimen, Sterile
- HTFCurette
- KMKDevice, Intravascular Catheter Securement
- FODDevice, Occlusion, Umbilical
- HDQDilator, Cervical, Fixed Size
- GENForceps, General & Plastic Surgery
- GDYGauze/Sponge, Internal, X-Ray Detectable
- LROGeneral Surgery Tray
- GDZHandle, Scalpel
- HRQHemostat
- EYJHolder, Ureteral Catheter
- GDGHook, Surgical, General & Plastic Surgery
- LRSI.V. Start Kit
- KOHInstrument, Manual, General Obstetric-Gynecologic
- KDCInstrument, Surgical, Disposable
- DYBIntroducer, Catheter
- KDDKit, Surgical Instrument, Disposable
- LYVLabel Or Tag, Sterile
- KAIMirror, Ent
- FMINeedle, Hypodermic, Single Lumen
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- LWKRazor, Surgical
- FMQRestraint, Protective
- GADRetractor
- FDGRetractor, Fiberoptic
- LRWScissors, General, Surgical
- JOKScissors, Medical, Disposable
- FPASet, Administration, Intravascular
- EPYSpeculum, Ent
- HICSpeculum, Vaginal, Nonmetal, Fiberoptic
- FMGStopcock, I.V. Set
- CCXSupport, Patient Position
- MCZSuture Removal Kit
- KYZSyringe, Irrigating (Non Dental)
- KGXTape And Bandage, Adhesive
- FTYTape, Measuring, Rulers And Calipers
- EFWToothbrush, Manual
- GAXTourniquet, Nonpneumatic
- LRQTracheostomy And Nasal Suctioning Kit
- DRSTransducer, Blood-Pressure, Extravascular
- FKGTray, Start/Stop (Including Contents), Dialysis
- LRPTray, Surgical
- BYYTube, Aspirating, Flexible, Connecting
- JZFTube, Ear Suction
- KNTTubes, Gastrointestinal (And Accessories)
- FPKTubing, Fluid Delivery
- GAZTubing, Noninvasive
- DQXWire, Guide, Catheter
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
Showing 25 of 313| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1095-2020 | 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 P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758486 PVP PREP PACK P758486 PVP PREP PACK P922260 ALCOHOL PREP PACK P928310 WET PREP TRAY P928310 WET PREP TRAY P948416 LACERATION PACK P966455A BREAST BIOPSY PACK-LF | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1094-2020 | 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 UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH UVT630 UMBILICAL/PICC/CHEST TUBE INS KIT UVT640 UMBILICAL CATHETER INSERTION TRAY (P/S) UVT665 UMBILICAL VESSEL CATHETER TRAY UVT730 UMBILICAL VESSEL INSERTION TRAY UVT795 UMBILICAL CATH TRAY UVT960A UMBILICAL PICC/INSERTION TRAY UVT960A UMBILICAL PICC/INSERTION TRAY UVT970 CVC/UMBILICAL CATHETER INSERTION TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1093-2020 | Centurion- PT225 PAIN MANAGEMENT TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1092-2020 | Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1091-2020 | Centurion- ENT SNUF3 SNUFFER KIT Y | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1090-2020 | Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1089-2020 | Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1088-2020 | Centurion- OR2020 BASIN SET | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1087-2020 | 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 DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101413 ADULT LUMBAR PUMP W NDLS MANO M101472A PREP PACK | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1086-2020 | Centurion- LC145 STERILE NICU LINE CHANGE KIT | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1085-2020 | Centurion- Port Draw Kit KNV30 PORT DRAW KIT | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1084-2020 | Centurion IVS3505 ULTRASOUND GUIDED PIV KIT | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1083-2020 | Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1082-2020 | Centurion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN) | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1081-2020 | Centurion- I86625 DEBRIDEMENT TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1080-2020 | Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1079-2020 | Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990 | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1078-2020 | Centurion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1077-2020 | Centurion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1076-2020 | Centurion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1075-2020 | Centurion-Suture Tray DYNDR1210A SUTURING TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1074-2020 | Centurion-Skin Prep Tray DYNDP1015 SKIN PREP TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1073-2020 | 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 KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT DM545 U OF U LVAD SENSITIVE SKIN DRESSING SYST DM550 VAD DRIVELINE MANAGEMENT TRAY DM555 LVAD MULTI-DAY DRIVELINE MGMT SIZE M/L DM565 LVAD DRESSING SYSTEM DM575 LVAD MULTI-DAY DRIVELINE MGMT SIZE S DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM690 VAD DRIVELINE MANAGEMENT BUNDLE DM710 VAD DAILY DRESSING CHANGE KIT DM720 DAILY LVAD MAINTENANCE KIT DM765 DAILY DRIVELINE MANAGEMENT SYSTEM DM770 WEEKLY DRIVELINE MANAGEMENT SYSTEM DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM805 DAILY LVAD DRIVELINE MANAGEMENT SYSTEM DM870 DAILY MAINTENANCE SYSTEM LVAD DM920 GAUZE DRIVELINE MANAGEMENT KIT DM925 SORBAVIEW DRIVELINE MANAGEMENT KIT DM935 DAILY DRIVELINE MANAGEMENT SYSTEM DM950 HIGH DRAINAGE LVAD TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1072-2020 | Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated | |
| Z-1071-2020 | Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM | Incomplete seals on the sterile package may compromise the sterility | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain