26 results
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28ms
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Sources: EU EUDAMED, US FDA
EQUAL DOSE
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814732·GENUMEDI EXTRA WIDE SAND SIZE V
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814787·GENUMEDI EXTRA WIDE SILVER SIZE V
Matreneu® Percutaneous Balloon Compression Kit
FDA UDI
Shenzhen Shineyard Medical Device Co.,Ltd.·06939698601340·This product primarily consists of five parts, ...
3.5 X 15.5mm Citrefix XPress System
FDA UDI
Acuitive Technologies, Inc.·00810027270863·
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3515
FDA 510(k)
FDA Class 1
·Hematology
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
FDA 510(k)
FDA Class 2
·Radiology
INFINITY EXPLORER
FDA 510(k)
FDA Class 2
·Cardiovascular
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·February 22, 2026
FETAL MONITOR/CARDIOTOCOGRAM
FDA Adverse Event
Injury
·BISTOS CO., LTD.·Product code HGL·January 29, 2018
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 9, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 26, 2011
HEARTMATE 3 VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·November 15, 2022
MIDAS REX MR8
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025
MOTOR MR8 ELECTRIC
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 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
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021