24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IPULSE, MODEL I400
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004066·PowerChem Neoprene Exam Gloves, Extra Extra Large
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606132·CHEST ROLL 16"L X 5" DIA 3/4" MEMORY FOAM WRAPP...
DRILL, DIA 5.5MM X 79MM, W/STOP
FDA UDI
Conformis, Inc.·00810933031824·
Azur Pure Helical
FDA UDI
Microvention, Inc.·00810170018145·Azur
JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
FDA 510(k)
FDA Class 2
·General Hospital
RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 4, 2024
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 26, 2013
LINK(R) MP(R) FIXATION SCREW
FDA Adverse Event
Injury
·WALDEMAR LINK GMBH & CO. KG·Product code KWA·May 6, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 24, 2008
Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J'' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code MMP·March 29, 2006
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
DURAMAX (TM) Hemodialysis Catheters, Stack Tip 28 cm Pre-Curve Basic Kit, Catalog Number/REF 10302813, 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