11 results
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28ms
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Sources: EU EUDAMED, US FDA
CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 1
·Microbiology
PTA BALLOON DILATATION CATHETERS
Device
EU MDD
·
Eu Md Class 2a
·BrosMed Medical Co., Ltd·On the market·1 country
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450637746·
HL888
FDA 510(k)
FDA Class 2
·Cardiovascular
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
FDA 510(k)
FDA Class 2
·Microbiology
HEARTMATE II LVAS, EUROPE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·April 30, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
ASR UNI FEMORAL IMPL SIZE 55
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 12, 2011
Achilles PTA Balloon Dilatation Catheter
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·BrosMed Medical Co., Ltd·1 device
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014
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