18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
KEY SURGICAL, INC.·10849771049927·Steinmann Pins, Single diamond, round end, 5/64...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704912435·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293784·
WECK CARDIAC PACING WIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
MALLORY HEAD MODULAR CALCAR
FDA 510(k)
FDA Class 2
·Orthopedic
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWA·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
CAPSUREFIX MRI
FDA Adverse Event
Injury
·MPRI·Product code NVN·April 22, 2013
SIG MOD TIB TRAY CEM COCR 2.5
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code JWH·April 15, 2011
OUTBACK RE-ENTRY CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DQY·July 7, 2008
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
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
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022