Data / Medical devices / United States / Centurion Medical Products, LP
Centurion Medical Products, LP: FDA-registered device maker in Williamston, MI, United States, 15 510(k) clearances
Centurion Medical Products, LP is registered with the FDA (registration 3008403546) in Williamston, MI, United States. It lists 31 device types. The FDA files 15 510(k) clearances under its listings, the newest dated May 24, 2022. 20 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3008403546
- Address
- 100 Centurion Way, Williamston, MI, United States, 48895
- Owner or operator
- Medline Industries, LP (1824619)
- Roles
- Specification developer
- First device listed
- August 21, 2001
- Registered through
- 2027
- Brand names listed
- Centurion CirClamp, Centurion Standard Extension Sets, Flush Connector, HUBGUARD, Medline Cardiovascular Procedure Kits, Medline General Surgery Tray, Medline Integrated Arterial Catheter, NEURO SUCTION TUBING / STERILE and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 24, 2022 | K213481 | Medline General Surgery Tray | LRO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| May 17, 2022 | K210548 | Medline Integrated Arterial Catheter | DQX | Substantially Equivalent | Centurion Medical Products | accessdata.fda.gov |
| December 3, 2021 | K212258 | Medline Cardiovascular Procedure Kit | LRO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| November 22, 2016 | K161408 | Compass Cast and MAP | DRS | Substantially Equivalent | Centurion Medical Products Corporation | accessdata.fda.gov |
| April 18, 2014 | K133624 | COMPASS CT, COMPASS CT PORT | DRS | Substantially Equivalent | Mirador Biomedical | accessdata.fda.gov |
| May 18, 2012 | K113565 | MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN | FOZ | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 14, 2011 | K112203 | COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST | DRS | Substantially Equivalent | Mirador Biomedical, Inc. | accessdata.fda.gov |
| June 23, 2011 | K103562 | CENTURION PRESSURE INJECTABLE EXTENSION SET | FPA | Substantially Equivalent | Centurion Medical Products Corporation | accessdata.fda.gov |
| January 20, 2011 | K103715 | COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE | DRS | Substantially Equivalent | Mirador Biomedical, Inc. | accessdata.fda.gov |
| August 28, 2008 | K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | FMQ | Substantially Equivalent | Tri-State Hospital Supply Corp. | accessdata.fda.gov |
| August 19, 1992 | K920884 | GUIDEWIRES, VARIOUS TYPES | DQX | Substantially Equivalent | Acme-Monaco Corp. | accessdata.fda.gov |
| April 1, 1991 | K910906 | CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS | FPK | Substantially Equivalent | Tri-State Hospital Supply Corp. | accessdata.fda.gov |
| August 9, 1989 | K885179 | INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD | DYB | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 28, 1989 | K890897 | CENTURION CIRCLAMP | HFX | Substantially Equivalent | Tri-State Hospital Supply Corp. | accessdata.fda.gov |
| January 23, 1979 | K782095 | STOPCOCKS, MANIFOLDS | DTL | Substantially Equivalent | Namic | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 11, 2019 | 84530 | Class II | Terminated | Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CI | Incomplete seals on the sterile package may compromise the sterility | accessdata.fda.gov |
| October 24, 2019 | 84165 | Class II | Terminated | Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955 | Sterile packaging incomplete seals may compromise sterility of the product | accessdata.fda.gov |
| August 28, 2019 | 83774 | Class II | Terminated | Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR | A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel. | accessdata.fda.gov |
| July 15, 2019 | 83542 | Class II | Terminated | Port full Access Tray Product Code: DT19330 | Supplier initiated recall of the GRIPPER Needles | accessdata.fda.gov |
| July 1, 2019 | 83329 | Class II | Terminated | STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting. | Potential for sterile packaging to be compromised | accessdata.fda.gov |
| June 24, 2019 | 83359 | Class II | Terminated | EPISTAXIS TRAY Kit Code: MNS10165 | Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manufacturer | accessdata.fda.gov |
| June 7, 2019 | 83202 | Class I | Terminated | Sheridan Endotracheal Tube contained inside Centurion kit code TC7855. | Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube. | accessdata.fda.gov |
| June 1, 2019 | 85494 | Class II | Terminated | Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit | False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer Plastic Lithium Heparin tubes with the IL GEM 4000 instrument. | accessdata.fda.gov |
| April 24, 2019 | 83584 | Class II | Terminated | PICC Line Accessory Kit CVI4285 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. | accessdata.fda.gov |
| March 29, 2019 | 82667 | Class II | Terminated | Sterile Nail Clipper Concave Edge (67710) | Compromised seal on the sterile barrier pouch. | accessdata.fda.gov |
| October 23, 2017 | 79329 | Class II | Terminated | SKIN STAPLE REMOVER | Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. | accessdata.fda.gov |
| July 5, 2017 | 78810 | Class II | Terminated | SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS. | Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manufactured by BD, sold in Centurion Convenience Kits. distributed between May 2016 and June 2017 due to notice received from BD's recall due to particulate that could be expelled out of the needle if used for injection. | accessdata.fda.gov |
| March 9, 2017 | 76730 | Class II | Terminated | POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components. | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging. | accessdata.fda.gov |
| October 21, 2016 | 75536 | Class I | Terminated | Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring. | The kits contain Multi-Med Single Lumen Catheters that have a potential for excess material to remain at the tip of the catheter from the manufacturing process. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death. | accessdata.fda.gov |
| January 19, 2016 | 73168 | Class II | Terminated | Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus Needless IV Connectors are used for single patient use in IV and blood administration sets withou | Convenience Kits contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being recalled by the manufacturer, RyMed Technologies, LLC. A component molding abnormality may cause female luer threads to crack, leading to potential for the mating tubing set to become detached and for the administration to be interrupted. Other components within th | accessdata.fda.gov |
| April 29, 2015 | 74604 | Class II | Terminated | Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY | Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufacturer, Medtronic. According to the notice received from Medtronic, the recall was initiated because some light covers may have splits or holes, which may result in the transfer of microorganisms from the light handle into the patient wound. | accessdata.fda.gov |
| October 23, 2014 | 70081 | Class II | Terminated | Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit) | According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper. | accessdata.fda.gov |
| July 25, 2014 | 68989 | Class II | Terminated | 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits. | Unit packages may exhibit open seals which impacts package integrity and potentially product sterility. | accessdata.fda.gov |
| March 31, 2011 | 58346 | Not yet classified | Terminated | Material, CVI2615, PICC INSERTION TRAY PICC Insertion Tray, Reorder CVI2615, CENTURION MEDICAL PRODUCTS CORP, WILLIAMSTON MI 48895, USA I www.centurionmp.com, CENTURION FACILITATES PICC LINE PLACEMENT | This voluntary recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9% utilized to make the products may contain visible particulates. | accessdata.fda.gov |
| January 14, 2011 | 57767 | Not yet classified | Terminated | Universal Insertion Tray Bundle, CV13530, Sterile, Centurion Medical Products Corp., Williamston, MI. These kits are used for dressing changes. | The firm is conducting a subrecall of kits containing Triad Groups alcohol prep pads. Triad initiated a recall of prep pads due to a concern about potential contamination of the products with an objectional orgainism, Bacillus cereus. | accessdata.fda.gov |
Compare with other makers
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- All makers of Retractor, Fiberoptic
Updated May 24, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.