13 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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BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
Safco Supergrade™ Mask
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310209273·Mask pink ASTM level 1
Zavation
FDA UDI
Zavation LLC·00842166108363·PLIF-R 09x27-10
Zavation
FDA UDI
Zavation LLC·00842166108370·PLIF-R 09x27-11
NA
FDA UDI
ZOE MEDICAL INCORPORATED·00851920007200·ECG 3-Lead Set, 1 meter, Snap-on, IEC.
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4
FDA 510(k)
FDA Unclassified
·Unknown
SNARE,FLEXIBLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRIDENT 0 DEG INSERT 40MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·August 25, 2017
ARTICUL/EZE BALL 28 +8.5 BL
FDA Adverse Event
Injury
·3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH·Product code JDI·March 26, 2013
CONSULTA CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·March 16, 2011
ONE TOUCH II METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·March 27, 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