12 results
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19ms
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Sources: EU EUDAMED, US FDA
GOOD LUBRICATIONS
FDA 510(k)
FDA Class 1
·General Hospital
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040161064·Channels Flex 31mm 55.04
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827943·ACHIMED ACHILLES SUPP BLACK VI
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717106678·Midway Select Flowable Composite A3.5 4 x 1.5g ...
MEDPOR PTERIONAL SURGICAL IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOSCANNER TRIGLYCERIDES TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CASSETTES FOR LPC FINEMESH PINK/1440
FDA Adverse Event
Injury
·LEICA MICROSYSTEMS NUSSLOCH GMBH·Product code IEO·March 21, 2013
WECK HEM-O-LOK CLIPS ML
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·February 10, 2011
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·March 28, 2008
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
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012