18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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XIA SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033520567·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033520536·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033520529·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033520550·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033520543·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033520574·
SCS DT-02 TRANSVERSE CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
SPAZZ
FDA 510(k)
FDA Class 1
·Physical Medicine
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 13, 2014
AXIOM ARISTOS VX PLUS
FDA Adverse Event
Injury
·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 20, 2013
CLEAR, PVC CONTRAST INJECTION LINE
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·February 4, 2011
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 14, 2008
IMPELLA CP
FDA Adverse Event
Death
·ABIOMED, INC.·Product code OZD·April 4, 2025
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022