23 results · 21ms · Sources: EU EUDAMED, 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