16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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