11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAPIDTEG TEG-ACT TEST
FDA 510(k)
FDA Class 2
·Hematology
CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BLADELESS VP 11MM ST W/FIXATION
FDA Adverse Event
Malfunction
·COVIDIEN FORMERLY US SUR·Product code GCJ·March 18, 2013
UNK ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·June 18, 2008
AQUAMANTYS 6.0 BIPOLAR SEALER
FDA Adverse Event
Injury
·SALIENT SURGICAL TECHNOLOGIES, INC.·Product code GEI·April 8, 2011
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 14mm 80 cm .014" REF PMP 4-7-14-80
FDA Recall
Terminated
·Product code FGE·January 29, 2004
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018