10 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
FDA 510(k)
FDA Class 2
·Hematology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496062615·CURVY 70 SHEER, SIZE ML-XL, VISONE, GRADUATED C...
SURGICAL SYSTEM WITH CRYOGUIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
M2A-MAGNUM MODULAR HEAD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 17, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·April 5, 2011
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·June 18, 2008
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
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 Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015