20 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYPODERMIC SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292978·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012733·K-Wires, Double diamond, .028-inch (.7mm) diame...
NA
FDA UDI
KEY SURGICAL, INC.·10849771049354·K-Wires, Double diamond, .028-inch (.7mm) diame...
Curve Disposable Sterile Monitor Drapes
FDA UDI
Spiggle & Theis Medizintechnik GmbH·04250676739872·77 cm x 47 cm (32" Display)
30 pcs...
NA
FDA UDI
Zimmer, Inc.·00889024132047·
DYNATECH JD7/JD7P COLPOSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CEMENT CHISELS
FDA 510(k)
FDA Class 1
·Orthopedic
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 24, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 3, 2012
ACCU-CHEK ADVANTAGE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·February 18, 2008
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·February 2, 2023
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
FDA Enforcement
Class II
·Terminated·CryoLife, Inc.·July 19, 2017
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025
TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 19, 2013