14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310215153·FG Diamond 856-012 round end taper coarse 5/pack
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827936·ACHIMED ACHILLES SUPP BLACK V
PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDLINE GROUNDING PAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·March 26, 2013
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 16, 2011
HEPARIN 100 UNITS PER ML
FDA Adverse Event
Injury
·MEDEFIL·Product code NZW·March 27, 2008
CENTURION LIGHT
FDA Adverse Event
Malfunction
·MEDICAL ILLUMINATION INTRNATION INC.·Product code FTD·November 4, 2019
CENTURION LIGHT
FDA Adverse Event
Malfunction
·MEDICAL ILLUMINATION INTRNATION INC.·Product code FTD·January 21, 2021
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014