14 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

CANDELA GENTLE YAG LASER SYSTEM

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

DUPLOGRIP

FDA 510(k)
FDA Class 2 ·General Hospital

MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE

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

DINAMAP PROCARE SERIES MONITOR

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code MWI·September 9, 2010

DINAMAP PROCARE SERIES MONITOR

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code MHX·September 9, 2010

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·February 27, 2013

INTEGRITY RX CORONARY STENT SYSTEM

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code MAF·March 16, 2011

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE LTD·Product code FRN·April 4, 2008

VUELOCK SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

VEULOCK SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

VEULOCK SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

VEULOCK SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014

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