27 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Stat Profile Prime Plus Analyzer System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEBAKEY MOSQUITO FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060821·DEBAKEY MOSQUITO FORCEPS STRAIGHT
OsteoMed
FDA UDI
OSTEOMED LLC·00845694098151·Periosteal Elevator, 3mm Straight Edge
Histofluor® Rodent LKS Fluorescent Antibody Test System
FDA UDI
IMMUNO CONCEPTS INC·M7491200403101·Rat LKS 4 Well Tiissue Slides - 10 Slides
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
FDA 510(k)
FDA Class 2
·Cardiovascular
AMS ACTICON NEOSPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code MIP·March 3, 2015
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 24, 2014
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 20, 2008
HOSPITAL FULL FACE MASK NON-VENTED
FDA Adverse Event
Death
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code MNT·August 11, 2011
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·July 1, 2013
CADD LEGACY 1 PUMPS - 6400
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·November 9, 2022
BRAUN - FILTER FLOW IV
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FPA·June 18, 2004
CADD LEGACY 1 PUMP MDL 6400
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·July 25, 2022
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·February 8, 2021
SINGLE USE GUIDWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·July 14, 2020
BAND-AID WATERBLOCK STRIPS 5 NEW AP
FDA Adverse Event
Injury
·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·October 14, 2020
BAND-AID WATERBLOCK STRIPS 10 NEW AP
FDA Adverse Event
Injury
·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·October 14, 2020
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·March 22, 2024
CABLE TENSIONER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·December 21, 2016