21 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

VASOTRAX

FDA 510(k)
FDA Class 2 ·Cardiovascular

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496001898·MAGIC 70, SIZE XL, FUMO, GRADUATED COMPRESSION ...

GRADIA®

FDA UDI
Gc America Inc.·D0470018981·GRADIA® gum Modifier (G244), 2.9 mL

GRADIA®

FDA UDI
Gc America Inc.·14548161393201·GRADIA® gum Modifier (G244), 2.9 mL

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 30, 2026

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 30, 2026

ULTRACISION SURG, DEV, BLADES 5MM OPEN

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·June 16, 2006

EEG WITH VIDEO, MODEL EX-NW

FDA 510(k)
FDA Class 2 ·Neurology

PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01

FDA 510(k)
FDA Class 2 ·General Hospital

PREMIUM PLUS CEEA

FDA Adverse Event
Malfunction ·US SURGICAL PUERTO RICO·Product code GDW·April 19, 2018

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·September 20, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·September 20, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·October 3, 2024

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 30, 2026

HS III PROXIMAL SEAL

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 12, 2013

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·February 25, 2011

REVERSE SHOULDER SYSTEM

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code HSD·February 25, 2008

Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

FDA Enforcement
Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

FDA Enforcement
Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012