25 results · 22ms · Sources: EU EUDAMED, 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