12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUANTUM SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERTE-STACK ANATOMIC PEEK STRUT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·May 5, 2020
DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BEHRING COAGULATION SYSTEM (BCS)
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·April 22, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 27, 2011
MULTI-LINK RX ZETA CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·July 3, 2008
3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM
FDA Adverse Event
Injury
·SYNTHES PRODUKTIONS GMBH·Product code NKG·February 8, 2018
LOCKSCR SYNAPSE TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018
LOCKSCR SYNAPSE TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·November 30, 2022