15 results · 22ms · 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.

ANKYLOS C/X DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

NOBELACTIVE INTERNAL RP 4.3X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

NOBELACTIVE INTERNAL NP 3.5X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

NOBELACTIVE INTERNAL NP 3.5X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

NOBELACTIVE INTERNAL RP 4.3X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

GYNECOLOGICAL LAPAROSCOPES

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

KOWA AUTOMATED TONOMETER KT-500

FDA 510(k)
FDA Class 2 ·Ophthalmic

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·May 10, 2011

GE OEC 6600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 29, 2008

Dunlee DA 200 & MX 200 CT X-Ray Tube Housing Assembly (989600087501); replacement x-ray tube housing assemblies; Dunlee, 555 North Commerce Street, Aurora, Illinois 60504 U.S.A.; part number 875-01

FDA Recall
Terminated ·Dunlee·Product code ITY·April 7, 2005

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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018