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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NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
FDA 510(k)
FDA Class 2
·Physical Medicine
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120243101·Carbide - Finishing Burs
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690114048·PS-R Insert, Size 3 x 10mm
Myo/Wire
FDA UDI
A & E MEDICAL CORPORATION·10841291100256·Temp Pacing Wire
PrimeSight
FDA UDI
SCHÖLLY FIBEROPTIC GmbH·04250480106310·Sinuscope 4 x 175 mm, 0°
DAVLITE MICROENDOSCOPE & ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
FDA 510(k)
FDA Class 2
·Orthopedic
DEVICE 8252410 NIM-NEURO 2.0 INTERFACE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code IKN·February 21, 2014
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·March 27, 2013
MEGA SUTURECUT NEEDLE DRIVER
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL·Product code NAY·March 7, 2011
QUANTUM MAVERICK MONORAIL BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·April 3, 2008
MERSILENE TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·November 4, 2024
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