49 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELITECROSS Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
HHM
FDA UDI
Oticon A/S·05707131285188·H160V2, DESIGNRITE 10 WL STG HHM
PULSAVAC®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024375000·High Capacity Tibial Plateau Brush Tip
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
X-SUIT NIR COVERED BILIARY METALLIC STENT
FDA Adverse Event
Malfunction
·MEDINOL LTD.·Product code FGE·December 27, 2017
G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 7, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 6, 2013
A7 ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017
Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports and OPTION-LOK, 15 drops/mL; a sterile Rx single patient device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160080401, list number 16008-01.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Primary Latex-Free Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced Y-sites, 0.2 micron filter, 104 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa; product 160880428, list number 16088-28.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-Free Primary Symbiq Pump Set, piggyback with backcheck valve, 2 CLAVE Y-sites, 105 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160900428, list number 16090-28.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-Free Symbiq Pump Set, convertible pin, 104 inch piggyback with backcheck valve, 2 CLAVE ports, 0.2 micron filter and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160220401, list number 16022-01.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Primary Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced sites, 105 inch, Latex-Free, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. made in Costa Rica; product 160890428, list number 16089-28.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160190401, list number 16019-01.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 160470701, REF 16047.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009