29 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SYGNAL DBM
FDA 510(k)
FDA Class 2
·Orthopedic
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004059·PowerChem Neoprene Exam Gloves, Extra Large
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606125·CHEST ROLL 16"L X 7"DIA 3/4" MEMORY FOAM WRAPPE...
iDuo® Patella Trial
FDA UDI
Conformis, Inc.·00850268007392·iDuo® 41mm Patella Trial Reusable Instrument
7230 ULTRASOUND IMAGING SYSTEM WITH TEI
FDA 510(k)
FDA Class 2
·Radiology
INTERCURE LTD. RESPI-LOW
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
ALIGN R URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·April 24, 2013
EON IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 22, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·July 22, 2008
BD PYXIS¿ MEDBANK TOWER
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·August 19, 2025
e-fix E20 power drive. The product is a wheelchair component/accessory.
FDA Recall
Terminated
·Frank Mobility Systems, Inc.·Product code ITI·August 1, 2004
DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit, Catalog Number/REF 10302804, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 8, 2010
DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 40 cm Straight Basic Kit, Catalog Number/REF 10302807, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 8, 2010
DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 24 cm Straight Basic Kit, Catalog Number/REF 10302803, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 8, 2010
DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 22 cm Straight Basic Kit, Catalog Number/REF 10302802, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 8, 2010
DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 32 cm Straight Basic Kit, Catalog Number/REF 10302805, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 8, 2010