14 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
FDA 510(k)
FDA Class 2
·Ophthalmic
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000399429·GRAFT DELIVERY 6061024 RECOVERY PLATFORM
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00610241·
TASMIN R 6°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014561·The basic shape of the TASMIN R devices is a ho...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610241·Mini Sprint-Brackets 5-5 Roth .022" 400 Bracket...
PASS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CYBERKNIFE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
E500 VENTILATOR SYSTEM
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016
CARE ASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·March 26, 2013
BONESOURCE CLASSIC, 25 GRAM
FDA Adverse Event
Other
·STRYKER ORTHOPAEDICS LIMERICK·Product code GXP·April 13, 2011
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL·Product code HQL·June 13, 2008
ENCOREANYWHERE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 17, 2016
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
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012