16 results · 22ms · 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.

TOP FINE INSULIN SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166

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

E.N.S.I. RETRACTABLE SAFETY SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

PROCISE XP

FDA Adverse Event
Malfunction ·ARTHROCARE CORPORATION·Product code GEI·April 11, 2013

CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·June 19, 2008

GO BED PLUS

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·April 11, 2011

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013

OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM

FDA Adverse Event
Injury ·BIOMET 3I·Product code DZE·December 18, 2023

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010

KYPHON KURVE BONE FILLER DEVICE 13GA

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO·Product code KIH·July 14, 2020

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·July 19, 2013

Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

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