14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME
FDA 510(k)
FDA Class 2
·Orthopedic
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331168260·landolt knife handles, 8 1/4" (21.0 cm)
PHOENIX HEMODIALYSIS DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 23, 2024
BEAVER BLADE
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code NBH·August 12, 2015
MINI ACCESS KIT (NON-VASCULAR)
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DRE·May 15, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·February 17, 2016
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011
HOSP SS FLEXX METER LASER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 17, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011