16 results
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24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704920928·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704284614·BECKMAN-WEITLANER RETRACTOR 9 1/2" 3X4 SHARP
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575046065·Orthopaedic broach - Endo Model Knee System
RESUSCI FLOW; RESUSCI FLOW 104
FDA 510(k)
FDA Class 2
·Anesthesiology
ACCOLADE RPS HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
LINEAR ST
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 1, 2024
PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 17, 2015
ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code OTN·June 5, 2013
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 6, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 22, 2011
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·April 25, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 4, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·February 18, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 26, 2019
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023