15 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.

EZ-IO

FDA 510(k)
FDA Class 2 ·General Hospital

OsteoMed

FDA UDI
OSTEOMED LLC·00845694091312·2.4mm x 8mm Fully Threaded Screw

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809848038·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE-...

BD MAX¿ STAPHSR

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code NQX·September 14, 2023

BD MAX¿ STAPHSR

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code NQX·September 14, 2023

CEREC VITABLOCKS MK2

FDA 510(k)
FDA Class 2 ·Dental

AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·September 3, 2010

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·April 11, 2013

TOTALCARE SPORT

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·March 16, 2011

FORCE FXC

FDA Adverse Event
COVIDIEN VALLEYLAB·Product code GEI·March 27, 2008

MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

FDA Adverse Event
Malfunction ·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·April 13, 2022

CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

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