10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
FDA 510(k)
FDA Class 2
·Cardiovascular
Bosworth TruRepair
FDA UDI
Harry J Bosworth Company·H6680921631·3 oz Repair Pwd, Clear
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123823·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 75mm
MICROSTREAM EXTERNAL BATTERY CHARGER
FDA 510(k)
FDA Class 2
·Anesthesiology
POLYTITER SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
ESSURE
FDA Adverse Event
Injury
·CONCEPTUS·Product code HHS·May 1, 2013
PATIENT DATA MODULE
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·April 27, 2011
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
FDA Adverse Event
Malfunction
·EBI, L.P.·Product code HRX·August 5, 2008
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024