14 results · 21ms · Sources: EU EUDAMED, 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