22 results
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42ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOMERS TRANSLUCENT ORTHODONTIC WIRE
FDA 510(k)
FDA Class 2
·Dental
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609836·MIDMARK 2" STANDARD
TINA-QUANT D-DIMER TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·April 26, 2013
AVS UNILIF SPACER 9 X 33 X 4DEG - 11MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MAX·April 14, 2011
BIOMET ARCOM AP PATELLA 3-PEG
FDA Adverse Event
Injury
·BIOMET, INC.·Product code JWH·July 15, 2008
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
FDA Adverse Event
Injury
·COOK INC·Product code FOZ·August 22, 2022
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
FDA Adverse Event
Injury
·COOK INC·Product code FOZ·August 22, 2022
TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·July 3, 2018
TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·July 3, 2018
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025
TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·June 25, 2018
Catheter, intravascular, therapeutic, short-term less than 30 days
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·November 10, 2022
1820334-2022-00399
FDA Adverse Event
Injury
·COOK INC·Product code LJS·March 16, 2022
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013