27 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CANNULA, W/SHARP OBTURATOR & VERESS NEED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACUMED
FDA UDI
Acumed LLC·10806378043901·2.8mm Hexalobe Lkg Drill Guide 6-65mm
KORONA
FDA UDI
HNM TOTAL RECON LLC·00841742100722·KORONA Tri Staple - (L)10mm,14mmx12mm
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA
FDA 510(k)
FDA Class 1
·General Hospital
0.25MM SLOTTED SCREWDRIVER BLD HEX COUPLING
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·May 8, 2014
RESERVOIR 1.8 ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 22, 2012
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·August 4, 2010
Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.
FDA Recall
Terminated
·Novoste Corporation·Product code JAJ·January 25, 2002
Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. The cane is used as an aid in walking or ambulation.
FDA Recall
Terminated
·Invacare Corporation·Product code KHY·November 6, 2012
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 8cm; product code/end item #000341; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18 Fr), length 4cm; product code/end item #000844; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 4cm; product code/end item #000846; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product code/end item #000342; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 4cm; product code/end item #000849 and #000859 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 8cm; product code/end item #000344 and #000735 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 8cm; product code/end item #000343 and #000443 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 4cm; product code/end item #000847 and #000857 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 8cm; product code/end item #000380 and #000379 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 4cm; product code/end item #000845; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007