21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
FLASH-LITE LED DENTAL CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
PYRENEES Cervical Plate System
FDA UDI
VB Spine LLC·10888857241879·Ratcheting Handle AO Connection
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COD COMPRESSION OSTEOTOMY DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·March 26, 2013
ENCORE 202/EL
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DRT·March 11, 2011
ROTALINK PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code MCX·March 26, 2008
UNKNOWN
FDA Adverse Event
Death
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·January 8, 2024
UNKNOWN
FDA Adverse Event
Death
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·January 9, 2024
UNKNOWN
FDA Adverse Event
Death
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·January 8, 2024
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·January 9, 2024
UNKNOWN
FDA Adverse Event
Death
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·January 8, 2024
UNKNOWN
FDA Adverse Event
Death
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·January 8, 2024
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·January 8, 2024
UNKNOWN
FDA Adverse Event
Death
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·January 8, 2024
UNKNOWN
FDA Adverse Event
Death
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·January 9, 2024
ALINITY I B12 REAGENT KIT
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code CDD·March 29, 2022
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 22, 2018
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