12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STRONG IMPLANT HANDPIECES
FDA 510(k)
FDA Class 1
·Dental
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978959269·DISTRACTOR 9092412 OBL HOUSING 12MM 4DEG
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198673·AK3 Ultra Insert Trial Size 4, 12mm
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
FDA 510(k)
FDA Class 1
·Ophthalmic
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INNOVA 4100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011
INNOVA 4100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011
M2A-MAGNUM 42-50 TPR INSRT STD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 3, 2013
T-PAL SPACER APPLICATOR HANDLE
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code LXH·September 16, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 2, 2011
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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