30 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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XTJF TYPE Q160VF1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004035·PowerChem Neoprene Exam Gloves, Medium
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606101·CHEST ROLL 15"LX6"DIA 3/4" MEMORY FOAM WRAPPED ...
iDuo® Patella Trial
FDA UDI
Conformis, Inc.·00850268007378·iDuo® 35mm Patella Trial Reusable Instrument
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 21, 2023
ADULT HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·February 15, 2010
RSP 4.0MM TAPERED TIP 6BOX ST
FDA Adverse Event
Malfunction
·A&E MEDICAL CORPORATION·Product code LRY·September 16, 2022
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 26, 2013
LINK(R) MP(R) NECK
FDA Adverse Event
Injury
·WALDEMAR LINK GMBH & CO. KG·Product code KWA·May 6, 2011
XCEL DILATING TIP TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·July 24, 2008
Misys Laboratory System versions 5.23 and 5.3
FDA Recall
Terminated
·Misys Healthcare Systems·March 27, 2003
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
DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 36 cm Straight Basic Kit, Catalog Number/REF 10302806, 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 55 cm Straight Basic Kit, Catalog Number/REF 10302809, 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