19 results
·
26ms
·
Sources: EU EUDAMED, US FDA
BioSign Flu A+B
FDA 510(k)
FDA Class 2
·Microbiology
Bernafon
FDA UDI
Bernafon AG·05711584080849·AQ CO5 MNR T, 2.4G NFM DPB MSIL/MAC ACCUQ
Border-Lock® Lower Tray #57
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172015967·Dental impression tray, single-use
KETTOSIL AND SILGINAT
FDA 510(k)
FDA Class 2
·Dental
ELECSYS PRECICONTROL MULTIMARKER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR SLANTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSJ·August 4, 2022
PROTECT-SLEEVE 12/8 L188
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·February 15, 2013
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·October 17, 2014
GYNECARE GYNEMESH
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·June 21, 2013
MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·CARDINAL HEALTH·Product code MGB·October 27, 2015
SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPU·September 9, 2025
SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPU·September 9, 2025
SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPU·September 9, 2025
SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPU·September 9, 2025
SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code NPU·September 9, 2025
SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPU·September 9, 2025
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
FDA Enforcement
Class II
·Completed·Vyaire Medical·December 13, 2023
MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018