15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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