15 results · 21ms · 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.

VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160

FDA 510(k)
FDA Class 2 ·Cardiovascular

PMMA disc

FDA UDI
Dentsply International Inc.·D00180824120·

Malecot

FDA UDI
COOK INCORPORATED·00827002151666·Malecot Catheter

RE-USEABLE MICROSTAAR INJECTOR, MSI-S

FDA 510(k)
FDA Class 1 ·Ophthalmic

FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 29, 2024

INNOVA 4100

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011

INNOVA 4100

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011

NDEHP PRIMARY PLUM PREPIERCED Y

FDA Adverse Event
Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·April 25, 2013

ASR XL TAP SLV ADAP 12/14+2

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 9, 2011

TRANSTAR STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FPO·July 22, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018