13 results · 25ms · Sources: EU EUDAMED, US FDA

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APPROACH CTO WIRE GUIDE

FDA 510(k)
FDA Class 2 ·Cardiovascular

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810057371219·STRETCHER PAD 30'" W X 2" H X 74" L DELUXE

WAVEWRITER ALPHA 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 18, 2024

DANIELS SHARPSMART REUSABLE SHARPS CONTAINER

FDA 510(k)
FDA Class 2 ·General Hospital

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)

FDA 510(k)
FDA Class 2 ·Hematology

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 26, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 21, 2011

HIRES 90K

FDA Adverse Event
Injury ·ADVANCED BIONICS LLC·Product code MCM·July 24, 2008

VIASYS

FDA Adverse Event
Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

DAVINCI SI

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 4, 2020

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

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

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020