16 results
·
42ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MEDLINE EXCEL RECLINCER WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
NAT - NUCLEIC ACID TRANSPORT
FDA 510(k)
FDA Class 1
·Microbiology
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·October 21, 2020
KLS MARTIN
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·November 17, 2020
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 28, 2013
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTIC·Product code FMK·June 19, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·April 14, 2011
ERBE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·October 23, 2024
VNGD ANT STBLZD BRG 10X75
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
VANGUARD CR ILOK FEM-LT 65
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
BIOMET CC I-BEAM TRAY 75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·September 20, 2024
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015