23 results
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23ms
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Sources: EU EUDAMED, US FDA
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
FDA 510(k)
FDA Class 2
·General Hospital
ELMED
FDA UDI
ELMED INCORPORATED·00842180170421·JORDAN-RICHARDSON-SIMPSON RETRACTOR, 1” x 1 1/2”
SAVANNAH
FDA UDI
SPINAL ELEMENTS·00840916151652·SAVANNAH®-LINK T-20 DRIVER
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776193232·JordanRichardsonSimpson Retr
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450695524·
Merit® Kit
FDA UDI
Merit Medical Systems, Inc.·00884450322444·
PHYSICA TT FIX. TIBIAL TRAY #5
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code MBH·March 24, 2022
SAVANNAH
FDA UDI
SPINAL ELEMENTS·00840916151706·SAVANNAH®-T T-20 DRIVER PRESS FIT
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
5C-ES CELL CONTROL, MODELS 7547191, 7547192
FDA 510(k)
FDA Class 2
·Hematology
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 8, 2013
XIENCE PRO LL EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·September 18, 2014
RENAISSANCE 29 P-WASH
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 16, 2011
QUICKIE LXI
FDA Adverse Event
Malfunction
·SUNRISE MEDICAL PRIVADA MISIONES·Product code IOR·July 27, 2021
POLARSTEM MODULAR HEAD FOR 21000662
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ORTHOPAEDICS AG·Product code LXH·August 17, 2022
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
FDA Enforcement
Class II
·Ongoing·Treace Medical Concepts, Inc.·September 4, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2015
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
FDA Recall
Open, Classified
·Treace Medical Concepts, Inc.·Product code HRS·June 2, 2024
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·September 22, 2016
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code PPD·June 11, 2024