16 results
·
39ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VENTILAIR II MEDICAL AIR COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
INTERCEPT-URETHRAL MICROCOIL
FDA 510(k)
FDA Class 2
·Radiology
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
FDA 510(k)
FDA Class 2
·Neurology
LINEAR 7.5 FR. 25CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019
LINEAR 7.5 FR. 25CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
ACL ADVANCE
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·July 13, 2005
2520274-2013-01866
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 8, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 29, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
LINEAR 7.5 FR. 40CC IAB
FDA Adverse Event
Injury
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 14, 2020
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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