12 results · 23ms · 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.

BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

HairCheck-DT (Cocaine)

FDA UDI
Quest Diagnostics·00868586000209·HairCheck-DT (Cocaine) is an ELISA test kit use...

WALLFLEX ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 16, 2025

DEVILBISS HUMIDIFIER

FDA 510(k)
FDA Class 2 ·Anesthesiology

AML HAIRCHECK-DT (COCAINE)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SYNREAM FLEXSHAFT

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTO·December 4, 2019

PINNACLE PELVIC FLOOR REPAIR KITS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 23, 2013

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEM, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 13, 2011

DAMON COPPER NITI WIRE

FDA Adverse Event
Malfunction ·ORMCO CORPORATION·Product code DZC·July 11, 2008

INNOVANCE D-DIMER

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code DAP·July 14, 2017

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, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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