14 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMPI CONTINUUM
FDA 510(k)
FDA Class 2
·Physical Medicine
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450536742·
PLASMA SPRAYED SHOULDER
FDA 510(k)
FDA Class 2
·Orthopedic
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 22, 2024
ALTRX NEUT 36IDX54OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 6, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
PLM A+3 MEDNET WRLSS
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2011
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022
PROFILE 3D
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 30, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018