14 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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TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D
FDA 510(k)
FDA Class 2
·Physical Medicine
Sharper Image
FDA UDI
Merchsource, LLC·00840397527243·
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221093882·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL3 -7T/...
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221062864·Mini Uni-Twin(TM) Bracket APC(TM) II UL3 -7T/11...
3M™ Unitek™ Uni-Twin™
FDA UDI
3M UNITEK CORPORATION·00652221016966·Mini Uni-Twin(TM) Bracket UL3 -7T/11A Hk .018 5/Pk
EECP THERAPY SYSTEM, MODEL TS3
FDA Adverse Event
Injury
·VASOMEDICAL, INC.·Product code DRN·December 30, 2002
HARRISON HAND HELD ADJUSTING INSTRUMENT
FDA 510(k)
FDA Unclassified
·Unknown
PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·December 11, 2007
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007
ESS305
FDA Adverse Event
Injury
·CONCEPTUS INC, USA·Product code HHS·March 19, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 16, 2011
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