11 results · 22ms · 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.

HDC SPIDER SCREW

FDA 510(k)
FDA Class 2 ·Dental

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809848427·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE EXTRA LA...

JETCAN HUBER NEEEDLE SET

FDA 510(k)
FDA Class 2 ·General Hospital

TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

EASYTRAK HEAVYWEIGHT GUIDE WIRE

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS·Product code DTB·November 9, 2006

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 11, 2013

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 16, 2011

LIFESHIELD EXT SET WITH LOCKING LUER 'T'

FDA Adverse Event
Malfunction ·HOSPIRA, LTD·Product code FPA·May 22, 2008

FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

FDA Enforcement
Class II ·Terminated·BioFire Diagnostics, LLC·April 24, 2019

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