15 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TISSUELINK BIPOLAR FLOATING BALL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040160944·Channels Flex 31mm 25.04
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717107337·Midway Select Disposable Diamonds 856L-016F Pkg/25
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450155592·
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 25, 2024
IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
FDA 510(k)
FDA Class 2
·Physical Medicine
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
FDA 510(k)
FDA Class 2
·Cardiovascular
EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM
FDA Adverse Event
APPLIED MEDICAL·Product code GCJ·March 20, 2013
REPLACEMENT TUBE
FDA Adverse Event
Malfunction
·ABBOTT NUTRITION·Product code KNT·February 10, 2011
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·March 28, 2008
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·December 4, 2017
BD VACUTAINER SST BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·April 29, 2021
BD VACUTAINER SST BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 17, 2021
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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