13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
FDA 510(k)
FDA Class 2
·General Hospital
Healqu
FDA UDI
Healqu LLC·00819143020611·Healqu Bordered Silicone Foam Dressing Lite 6in...
KneeAlign 2
FDA UDI
Orthalign, Inc.·00810832030386·KneeAlign 2 Instrument Tray Base
TC-PLUS SOLUTION KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
DIAMOND ALOE VERA, STERILE
FDA 510(k)
FDA Unclassified
·Unknown
BIOLOX AND DELTA ARTICUL/EZE FEMORAL HEAD 36MM
FDA Adverse Event
DEPUY·Product code JDI·March 18, 2013
X3 TRIATHLON CS INSERT #7 11MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·March 7, 2011
TA 60-4.8 SINGLE USE RELOADABLE STAPLER
FDA Adverse Event
Injury
·PONCE - USS·Product code GAG·March 27, 2008
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·July 13, 2018
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·July 13, 2018
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·July 13, 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