15 results
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30ms
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Sources: EU EUDAMED, US FDA
LEKTROGEL, MODEL LK3001
FDA 510(k)
FDA Class 2
·Neurology
Pratt Ex large, Light Weight
FDA UDI
MEDGYN PRODUCTS, INC.·M803030887·Pratt Ex large, Light Weight 69-71 Fr (23-23.6 mm)
Vital Signs™
FDA UDI
AirLife Finland Oy·10889483576496·Vital Signs™ ECG Paper, MAC® Series, 8 years Im...
HELLIGE MARQUETTE 2030887-001
Device
EU MDR
·
Eu Md Class 1
·ISD MEDITECH SDN. BHD.·Not intended for eu market
HELLIGE MARQUETTE 2030887-001
Device
EU MDR
·
Eu Md Class 1
·ISD MEDITECH SDN. BHD.·Not intended for eu market
Vermed
FDA UDI
GRAPHIC CONTROLS ACQUISITION CORP·00009336000388·Electrocardiographic recording paper
DRX HBA1C
FDA 510(k)
FDA Class 2
·Hematology
INSULIN PEN NEEDLE ADAPTER
FDA 510(k)
FDA Class 2
·General Hospital
INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·November 12, 2021
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·April 2, 2013
MAT TOURNIQUET
FDA Adverse Event
Injury
·PYNG MEDICAL·Product code KCY·March 22, 2011
GE OEC 8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
BACFIX ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020
Vital SignsTM ECG Paper
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·AirLife Finland Oy·1 device
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