42 results · 27ms · Sources: EU EUDAMED, US FDA

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NEO NEST

FDA 510(k)
FDA Class 1 ·Physical Medicine

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

COROENT INTERLOCK SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 4, 2024

COULTER® LH 500 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·May 14, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

QUANTUM TTC ESOPHAGEAL BALLOON DILATOR

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNQ·May 26, 2011

ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

FDA Adverse Event
Malfunction ·MAKO SURGICAL·Product code OLO·April 25, 2014

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 22, 2024

ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

FDA Adverse Event
Malfunction ·MAKO SURGICAL·Product code NPJ·April 25, 2014

LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 13, 2023

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·December 17, 2024

LOGIC FEMORAL PS CEM LEFT SZ 3.5

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·March 5, 2025

LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·June 30, 2022

LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 5, 2024

LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 11, 2024

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 22, 2024

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 26, 2023

OPTETRAK LOGIC

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 7, 2023

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 11, 2023