10 results
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26ms
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Sources: EU EUDAMED, US FDA
SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS
FDA 510(k)
FDA Class 2
·Physical Medicine
COLLAMEND FM IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3
FDA 510(k)
FDA Class 2
·Cardiovascular
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·February 20, 2020
PINNACLE 300 ACET CUP 50MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·May 9, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 24, 2012
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 17, 2010
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·February 23, 2023
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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