17 results
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21ms
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Sources: EU EUDAMED, US FDA
CHASE CARDIOVASCULAR PATCH KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTUX CAD/CAM Disc. 98.5X18mm A3. MN
FDA UDI
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A·07701126712220·PORTUX CAD/CAM Disc. 98.5X18mm A3. MN
infinity OCTAGON BL RC Healing abutment, conical Ø 6.5 mm GH 2.0 mm
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50220931·BL RC Healing abutment, conical Ø 6.5 mm GH 2.0...
ATRIUM LITE MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AETMED IMAGE PROCESSING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
DINAMAP PROCARE SERIES MONITOR
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MWI·September 9, 2010
DINAMAP PROCARE SERIES MONITOR
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·September 9, 2010
VIASYS
FDA Adverse Event
Malfunction
·CAREFUSION 207, INC·Product code CBK·October 26, 2009
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·March 26, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·February 28, 2011
ANGIO-SEAL
FDA Adverse Event
Injury
·ST. JUDES·Product code MGB·March 27, 2008
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·October 7, 2010
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC·Product code CBK·October 27, 2009
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC.·Product code CBK·October 27, 2009
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018