92 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
FDA 510(k)
FDA Class 2
·Hematology
NA
FDA UDI
KEY SURGICAL, INC.·10849771052361·Steinmann Pins, Single diamond, round end, 2.0m...
TRELLIS-6 PERIPHERAL INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDERED VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HXX·October 19, 2017
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 14, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 15, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011
AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·April 15, 2021
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DQX·July 2, 2024
BENTSON STRAIGHT FIXED CORE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·August 12, 2024
AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·April 25, 2022
SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·May 3, 2024
BENTSON STRAIGHT FIXED CORE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·June 4, 2024
SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·September 1, 2022
BENTSON STRAIGHT FIXED CORE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 8, 2024
LUNDERQUIST-RING TORQUE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·September 28, 2021
SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 7, 2022
INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·August 23, 2018
COONS INTERVENTIONAL WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·February 21, 2022