12 results
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27ms
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Sources: EU EUDAMED, US FDA
RITA SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854004302·ULTRAPOWER BUR, ROUND (LIME) (COPPER), 6 MM
ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LZO·August 12, 2024
ECHELON*FLEX60
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 26, 2013
TRIATHLON CR CEMENTED #3 FEMORAL COMPONENT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·March 8, 2011
SIGMA STAB GVF INS 2.5 12.5MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·March 28, 2008
3DMAX LIGHT
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·September 19, 2025
3DMAX
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·September 19, 2025
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
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014