24 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Erisma® LP Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10887488107363·MEDICAL IMAGING TRAY
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SWABBABLE CAP, MODEL 60205
FDA 510(k)
FDA Class 2
·General Hospital
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·September 12, 2019
RAD-57 CONFIGURABLE PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·June 24, 2019
HUMAPEN LUXURA HALF-DOSE PEN
FDA Adverse Event
Injury
·ELI LILLY AND COMPANY·Product code NSC·June 14, 2013
MITROFLOW AORTIC PERICARDIAL HEART VALVE
FDA Adverse Event
Other
·SORIN GROUP CANADA INC. MITROFLOW DIVISION·Product code LWR·June 24, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 2, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·February 12, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·March 8, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·February 18, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 3, 2020
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 2, 2020
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·July 26, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·November 20, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·November 8, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·July 12, 2024
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
FDA Enforcement
Class II
·Terminated·Anjon Holdings·August 19, 2020