11 results
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19ms
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Sources: EU EUDAMED, US FDA
NAKAO SNARE II AND NAKAO SNARE III
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743700·ACHIMED ACHILLES SUPP SAND I
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
FDA 510(k)
FDA Class 1
·Microbiology
STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
PARAPAC 'MEDIC' (K020899)
FDA Adverse Event
Death
·SMITHS MEDICAL INTERNATIONAL·Product code BTL·August 6, 2004
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007
8.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·March 26, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 16, 2011
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
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
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014