11 results · 36ms · 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.

NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS

FDA 510(k)
FDA Class 2 ·Anesthesiology

Channel Drain

FDA UDI
C. R. Bard, Inc.·00801741049972·Channel Drain, 32Fr. Round Hubless Full Fluted

IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO

FDA 510(k)
FDA Class 2 ·Radiology

HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB

FDA 510(k)
FDA Class 2 ·Immunology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

RENAL UROLOGY STENT K072293

FDA Adverse Event
Other ·FOSSA MEDICAL INC·Product code FAD·April 10, 2014

TOTALCARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·April 4, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 28, 2011

SPRINT

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code LWS·July 10, 2008

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