6,047 results
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024
Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.
FDA Enforcement
Class II
·Ongoing·Community Products, LLC·January 28, 2026
Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the number of liners and lids purchased in one case without the individual boxes. The "H" denotes a single quantity when being ordered.
FDA Enforcement
Class II
·Ongoing·Medline Industries Inc·October 30, 2019
Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds.
FDA Enforcement
Class II
·Ongoing·Community Products, LLC·January 28, 2026
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point of access in the patient. Catalog Number: 1025-011-500
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·July 10, 2024
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.
FDA Enforcement
Class II
·Ongoing·Merz North America, Inc.·November 25, 2020
30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
FDA Enforcement
Class II
·Ongoing·B. Braun Medical, Inc.·November 15, 2023
30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
FDA Enforcement
Class II
·Ongoing·B. Braun Medical, Inc.·November 15, 2023
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
FDA Enforcement
Class II
·Ongoing·Stryker Medical Division of Stryker Corporation·August 18, 2021
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·April 19, 2023
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·April 19, 2023
Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·February 24, 2021