19 results · 22ms · Sources: EU EUDAMED, US FDA

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N ANTISERA TO HUMAN CERULOPLASMIN

FDA 510(k)
FDA Class 2 ·Immunology

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 24, 2015

IMBIBE BONE MARROW ASPIRATION SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

INION GTR BIODEGRADABLE MEMBRANE SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

KINETRA

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·December 16, 2011

SOLETRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 26, 2012

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 6, 2015

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 11, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 11, 2013

UNKNOWN PREFILL

FDA Adverse Event
Malfunction ·TYCO HEALTHCARE/KENDALL·Product code NZW·May 28, 2008

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·April 13, 2011

PORTEX® ULTRAPERC® SINGLE DILATOR TUBE

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD; INC.·Product code JOH·October 17, 2019

ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0°, RETRO

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSD·November 21, 2018

ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-18

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code KWT·November 21, 2018

ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-0

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code KWS·November 21, 2018

ANATOMICAL SHOULDER FRACTURE, HUMERAL STEM, 7-130

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code KWS·November 21, 2018

PORTEX BLUE LINE ULTRA SUCTIONAID PERCUTANEOUS DILATION TRACHEOSTOMY KIT

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD, INC.·Product code JOH·October 14, 2019

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 24, 2014

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