26 results · 23ms · Sources: EU EUDAMED, 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