19 results · 26ms · Sources: EU EUDAMED, US FDA

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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