26 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NXSTAGE EXPRESS FLUID WARMER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017798·K-Wire, Double Ended, Trocar Point, Diameter 0....
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017781·K-Wire, Double Ended, Trocar Point, Diameter Si...
ICU Medical
FDA UDI
ICU MEDICAL, INC.·00840619046422·Central Venous Catheter, Heparin Coated, 2 Lume...
AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMS PERIGEE SYSTEM
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
ILET BIONIC PANCREAS
FDA Adverse Event
Malfunction
·BETA BIONICS INC.·Product code QFG·January 8, 2026
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code OUT·May 31, 2013
DUAL TRIGGER ROTARY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 17, 2011
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC EUROPE SARL·Product code LGW·August 28, 2008
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·May 20, 2020
POLARIS SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DQE·January 2, 2020
PEDICLE SCREW UNSPECIFIED
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021
PEDICLE SCREW UNSPECIFIED
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021
PEDICLE SCREW UNKNOWN TYPE/SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021
CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·December 3, 2020
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KXA·October 14, 2019