23 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ST AIA-PACK INTACT PTH ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496063605·SOCKS FOR YOU BAMBOO TYPE, SIZE L, GRIGIO, GRAD...
LFIT
FDA UDI
Howmedica Osteonics Corp.·07613327072358·Femoral Head
AEROECLIPSE II BREATH ACTUATED NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
INSCOPE 3-STAGE BALLOON DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·April 21, 2022
TRIDENT HEMISPHERICAL SOLID BK 56MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·May 12, 2011
TRIDENT PSL HA CLUSTER 54MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·December 22, 2010
PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·September 14, 2010
TRITANIUM REVISION ACETABULAR
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·November 13, 2009
11/13 S-ROM 40MM M SPEC+9
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC 1818910·Product code JDI·April 17, 2013
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·June 19, 2008
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 19, 2011
ATRICURE BIPOLAR SYSTEM
FDA Adverse Event
Injury
·ATRICURE, INC.·Product code GEI·July 28, 2010
TRIDENT 0° X3 INSERT 36MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·February 5, 2013
TRIDENT 10° X3 INSERT 36MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·June 25, 2013
Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,13656, 113656A, and 113656B for use in DiaSorin Antibody Reagent Set for Lp(a) SPQ Test System .
FDA Recall
Terminated
·Diasorin Inc.·Product code DFC·January 10, 2005
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
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018