10 results
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21ms
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Sources: EU EUDAMED, US FDA
JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)
FDA 510(k)
FDA Class 2
·Cardiovascular
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
FDA 510(k)
FDA Class 3
·Cardiovascular
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
FDA 510(k)
FDA Class 2
·Anesthesiology
PELVICOL 6 X 8 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·April 24, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 16, 2014
HEARTSTRING PROXIMAL SEAL, 4.5 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·April 19, 2011
T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE
FDA Adverse Event
Injury
·MERCURY MEDICAL·Product code CAI·September 29, 2015
NEONATAL PATIENT CIRCUIT KIT
FDA Adverse Event
Injury
·MERCURY MEDICAL·Product code CAI·September 21, 2015
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,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024