16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRA-CBX
FDA 510(k)
FDA Class 2
·Cardiovascular
FABRIC 450* TOWEL DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·March 6, 2013
UNIVERSAL DRIVER SHAFT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·January 28, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 8, 2014
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·July 30, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·November 24, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·July 15, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·September 9, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·September 4, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·September 24, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·January 12, 2026
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·March 4, 2026
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·February 19, 2026
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026