14 results · 20ms · Sources: EU EUDAMED, US FDA

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TELEMEDICINE SYSTEM MODEL VMS-01

FDA 510(k)
FDA Class 2 ·Cardiovascular

Sklar®

FDA UDI
SKLAR CORPORATION·10649111116513·CUFF BLADDER BULB VALVE LG ADT

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 20, 2013

SE-100 VACUUM ERECTION DEVICE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HARDYDISK CLINDAMYCIN, 2MCG

FDA 510(k)
FDA Class 2 ·Microbiology

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 9, 2020

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 15, 2015

9301

FDA Adverse Event
Injury ·UNKNOWN·Product code DTB·July 29, 1994

XACT CAROTID STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIM·March 10, 2014

HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code MNB·April 17, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 19, 2011

OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION·Product code LIT·June 16, 2008

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