11 results · 17ms · Sources: EU EUDAMED, US FDA

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RIAPHASE (125I) PROST. ACID PHOSPH. KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NA

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·20763000878812·INSTRUMENT 803-043 GUIDEWIRE

Medtronic Reusable Instruments

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·20673978035073·INSTRUMENT 803-043 GUIDEWIRE

SURGICAL TITANIUM MESH SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201

FDA 510(k)
FDA Class 2 ·Cardiovascular

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2014

HEARTSTART ONSITE

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 19, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 26, 2007

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

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024