14 results · 20ms · Sources: EU EUDAMED, US FDA

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LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN

FDA 510(k)
FDA Class 2 ·Cardiovascular

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450158500·

INTER-OP DURASUL ACETABULAR INSERTS (4MM)

FDA 510(k)
FDA Class 2 ·Orthopedic

PREFERNCE IMRT TREATMENT PLANNING MODULE

FDA 510(k)
FDA Class 2 ·Radiology

G2 FILTER SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 21, 2007

G2 FILTER SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·May 15, 2007

RECOVERY G2 FILTER SYSTEM - JUGULAR DELIVERY KIT

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·March 23, 2010

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·April 11, 2013

OCUSCAN RXP

FDA Adverse Event
Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code IYO·April 8, 2011

BRAVO

FDA Adverse Event
Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·May 22, 2008

G2 FILTER SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·September 21, 2007

Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G

FDA Enforcement
Class II ·Ongoing·Merit Medical Systems, Inc.·October 23, 2024

Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·August 19, 2024

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