20 results
·
55ms
·
Sources: EU EUDAMED, US FDA
HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DVR PLATE
FDA Adverse Event
Malfunction
·HAND INNOVATIONS, INC.·Product code HRS·August 16, 2002
DVRA R RIGHT
FDA Adverse Event
Malfunction
·HAND INNOVATIONS, INC.·Product code HRS·August 10, 2006
ARTELON CMC SPACER
FDA Adverse Event
Injury
·ARTIMPLANT SOLD BY SMALL BONE INNOVATIONS·Product code KYI·January 31, 2012
UNKNOWN LOCKING PLATE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HRS·August 17, 2017
CALCANEAL COMPRESSION SCREW, RIGHT A3 NAIL M10 X 10MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HSB·December 22, 2015
UNKNOWN LOCKING PLATE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HRS·August 17, 2017
CITADEL PLUS
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH POLSKA·Product code FNL·February 9, 2018
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B.BRAUN MELSUNGEN AG·Product code FRN·April 5, 2023
UNK - CONSTRUCTS: PLATE/SCREWS
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·December 4, 2019
ULTHERA
FDA Adverse Event
Injury
·ULTHERA, INC. MERZ DEVICE INNOVATION CENTER·Product code OHV·June 8, 2017
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
FDA Recall
Terminated
·Delfi Medical Innovations, Inc.·Product code KCY·April 3, 2019
DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile
FDA Recall
Terminated
·Delfi Medical Innovations, Inc.·Product code KCY·April 3, 2019
International Associates Auditing & Certification Limited
Authorized representative
🇮🇪 Ireland·46 Manufacturers·161 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·February 6, 2024
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices