13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOSS MIAMI SPINAL SYSTEM PIN NUT
FDA 510(k)
FDA Class 2
·Orthopedic
SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
FDA 510(k)
FDA Class 2
·Cardiovascular
SOCRATES ROBOTIC TELEMONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·June 4, 2019
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·May 17, 2019
EASYPUMP: 100 ML, 2 ML/HR
FDA Adverse Event
Injury
·I-FLOW CORP.·Product code MEB·March 26, 2013
SEVEN CONTINOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·March 9, 2011
3 X 3 DUREPAIR DURA SUBSTITUTE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code GXQ·April 2, 2008
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·May 29, 2019
Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results.
FDA Recall
Terminated
·Misys Healthcare Systems·Product code JQP·July 21, 2003
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
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018