12 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION

FDA 510(k)
FDA Class 2 ·Radiology

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033244·Baltic Denture System BDLoad BDLoad Sw6 PLSEbm...

COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE

FDA 510(k)
FDA Class 1 ·General Hospital

MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 12, 2026

BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·December 22, 2022

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·April 3, 2013

ROTATING MULTIPLE CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 30, 2011

GREENFIELD 12FR SS VENA CAVA FILTER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code DTK·April 15, 2008

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024