18 results · 21ms · Sources: EU EUDAMED, US FDA

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AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS

FDA 510(k)
FDA Class 2 ·Anesthesiology

SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010

FDA 510(k)
FDA Class 2 ·Dental

PORTADUR P 2, MODEL #2031

FDA 510(k)
FDA Class 2 ·Dental

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 16, 2019

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 7, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 5, 2012

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 31, 2012

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 29, 2012

GREENLIGHT HPS BPH FIBER OPTIC

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 4, 2013

INTELLIVUE MP5

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 30, 2011

FINELINE II EZ

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 15, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 14, 2012

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 12, 2015

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 31, 2012

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 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