11 results · 36ms · Sources: EU EUDAMED, US FDA

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PHAROS EXCIMER LASER SYSTEM, MODEL EX-308

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM

FDA 510(k)
FDA Class 2 ·Microbiology

TRANSONIC SYRINGE WARMER, MODEL SYR-1000

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

HAHN IMPLANT Ø4.3 X 13 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 25, 2021

UNKNOWN HIP ACETABULAR LINERS

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 14, 2021

GO BED PLUS

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·April 11, 2011

ASR ACETABULAR IMPLANT 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 17, 2013

HYDROTHERMABLATOR PROCEDURE SET

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MNB·June 19, 2008

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015