16 results · 21ms · Sources: EU EUDAMED, US FDA

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ULTRASONIC SCALER, VARIOS 560

FDA 510(k)
FDA Class 2 ·Dental

N LATEX B2-MICROGLOBULIN

FDA 510(k)
FDA Class 2 ·Immunology

SOLO-CARE PLUS MULTIPURPOSE SOLUTION

FDA 510(k)
FDA Class 2 ·Ophthalmic

PROFEMUR(R) Z STEM PLASMA SPRAYED

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·April 17, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 12, 2011

ZENITH FLEX

FDA Adverse Event
Injury ·COOK, INC.·Product code MIH·June 17, 2008

UNKNOWN KNEE ARTICULAR SURFACE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 12, 2018

UNKNOWN KNEE FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 12, 2018

UNKNOWN KNEE TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 12, 2018

UNKNOWN KNEE TIBIAL TRAY

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code NJL·February 25, 2022

UNKNOWN KNEE FEMORAL

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·February 25, 2022

UNKNOWN KNEE TIBIAL INSERT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code NJL·February 25, 2022

UNKNOWN KNEE PATELLA

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·February 25, 2022

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

Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017