9 results · 27ms · 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.

AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450543511·

M2376A DEVICELINK SYSTEM, MODEL M2376A

FDA 510(k)
FDA Class 2 ·Cardiovascular

NUCLEOTOMY INTRADISCAL CATHETER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TOTAL ASR ACET IMP SIZE 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 6, 2013

XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Death ·AV-TEMECULA-CT·Product code NIQ·September 16, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 12, 2011

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