14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADD POWER FAMILY , MICRO ADDSTAT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electrode for ABL analyzers
FDA UDI
Radiometer Medical ApS·05700699456144·E777 pH electrode for ABL7XX/8XX
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BTE HEARING AID MULTIFOCUS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Malfunction
·COOK INC·Product code MIH·December 3, 2018
Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00
FDA Enforcement
Class II
·Terminated·Reckitt Benckiser LLC·March 20, 2019
ABL800 FLEX
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code CHL·September 13, 2024
Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00
FDA Recall
Terminated
·Reckitt Benckiser LLC·Product code MOL·December 19, 2018
OT VERIO TEST STRIPS
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 6, 2013
LIVIAN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 4, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 2014
Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
FDA Enforcement
Class II
·Terminated·Reckitt Benckiser LLC·October 3, 2018
Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
FDA Recall
Terminated
·Reckitt Benckiser LLC·Product code MOL·July 23, 2018
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024