11 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QLICKSMART
FDA 510(k)
FDA Class 2
·General Hospital
T2 - NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·May 21, 2025
T2 - NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·June 23, 2025
KETONE TEST A SANWA STANDARD
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CALF SERUM, CATALOG NO. 110-1125
FDA 510(k)
FDA Class 1
·Hematology
PROSIMA PELVIC FLOOR REPAIR KIT
FDA Adverse Event
Injury
·ETHICON INC·Product code OTP·February 28, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 10, 2011
ACCURUS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 7, 2014
T2 - NAIL HANDLE
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·May 21, 2025
ARCHITECT C4000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·July 31, 2018
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024