14 results · 25ms · 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.

ATB ADVANCED PTA DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Sklar®

FDA UDI
SKLAR CORPORATION·10649111203060·DEJURINE SPARE RUBBER

PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET

FDA 510(k)
FDA Class 2 ·Anesthesiology

COMPLETE BRAND MULTI-PURPOSE SOLUTION

FDA 510(k)
FDA Class 2 ·Ophthalmic

CP87170 DE MUENCHEN

FDA Adverse Event
Death ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

HEDSTROEM FILE

FDA Adverse Event
Malfunction ·DENTSPLY MAILLEFER·Product code EKS·February 26, 2013

HUT EXT DR FINAL ASSY-REVERSE

FDA Adverse Event
Malfunction ·LIEBEL-FLARSHEIM CO.·Product code KQS·March 22, 2011

SHILEY FEN LPC

FDA Adverse Event
Injury ·COVIDIEN/ FORMERLY TYCO·Product code BTO·June 18, 2008

ZIMMER M/L TAPER FEMORAL STEM

FDA Adverse Event
Injury ·ZIMMER INC·Product code LZO·February 17, 2016

KINECTIV MODULAR NECK

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code KWA·May 26, 2016

ARCHITECT IPTH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code CEW·March 19, 2025

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

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