15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ADAPT OPEN ACCESS PORT, MODEL 41233
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AVID-NIT LOSS OF RESISTANCE SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 7, 2010
MODIFIED KUGEL PATCH
FDA Adverse Event
Malfunction
·DAVOL INC.·Product code FTL·September 1, 2011
ASR ACETABULAR IMPLANT 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·March 26, 2013
ARCHITECT HAVAB IGM REAGENT
FDA Adverse Event
Malfunction
·ABBOTT·Product code LOL·March 17, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·March 19, 2008
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 27, 2013
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 11, 2023
DHF 06 HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALY·Product code KDI·May 22, 2025
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 25, 2016
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·August 2, 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