11 results · 24ms · Sources: EU EUDAMED, US FDA

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UltraLinq

FDA 510(k)
FDA Class 2 ·Radiology

MAXIM VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304205857·

MAXIM® VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00887868225925·

FREQUENCER

FDA 510(k)
FDA Class 2 ·Anesthesiology

ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 17, 2024

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 25, 2014

ZEPHYR XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014

EEA XL 28MM SINGLE-USE STAPLER

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY USSC·Product code GDW·May 24, 2013

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 28, 2011

PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014