25 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VENUS BASIC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Mini Wright
FDA UDI
CLEMENT CLARKE INTERNATIONAL LIMITED·05023323030856·MWPFM STD ATS CLAM
SOLID CANCELLOUS LAG SCREW
FDA UDI
Biomet Orthopedics, LLC·00887868003882·
FlexStep
FDA UDI
Liftup A/S·05714420030855·FlexStep V2, 900, 6 step, indoor
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 85mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665038477·
NexxZr™ / W-98-25-UT-B300-ML
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271139030·
RIVA Posterior Fixation System
FDA UDI
XENIX MEDICAL LLC·00840493414713·Nav Pedicle Tap, 8.5mm
NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2025
Widex
FDA UDI
Widex A/S·05706069342208·WIDEX BABY440 BTE (Pearl blue ) RC coil
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 9, 2013
SYNCHRON LX®I 725 SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JGS·May 25, 2011
PERFIX PLUG
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·August 8, 2008
ACTIVA PC
FDA Adverse Event
Malfunction
·MPROC, JUNCOS·Product code MHY·July 13, 2009
CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 2.5 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL (MDR)·Product code LXH·August 19, 2015
CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 4 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL (MDR)·Product code LXH·August 19, 2015
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024
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