14 results
·
39ms
·
Sources: EU EUDAMED, US FDA
PICC Maximal Barrier Nursing Kit
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550155·GENUMEDI PT KNEE SUP SILVER L EW VI
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277132970·Cheng Trephine 20mm
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973102076·Poly Insert MPCS, Size 6L, 16mm
ZOLL IVTM SOLEX CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·December 13, 2020
BIOMEDIX PADNET LAB
FDA 510(k)
FDA Class 2
·Cardiovascular
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TARGET DEVICE GAMMA3 300X160MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·November 13, 2012
PLATE OTIS-C PLUS RIGHT
FDA Adverse Event
Injury
·S.B.M. SAS·Product code HRS·May 21, 2019
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·March 20, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·September 26, 2014
NONE
FDA Adverse Event
Malfunction
·INVACARE·Product code INM·June 21, 2011
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
FDA Enforcement
Class II
·Ongoing·Ventana Medical Systems, Inc.·August 28, 2024
5.5 EXP VERSE DI SET SCREW
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·February 9, 2021