17 results · 22ms · Sources: EU EUDAMED, US FDA

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DARCO LOCKING BONE PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SOAR Retractor System

FDA UDI
SPINEOLOGY INC.·M7603061808·18mm x 80mm Portal Tube

Millennia Software

FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C1MA080·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694017657·MFx Tag, Auto-Drive Angulated Locking Screw, 8mm

DORO HEADREST SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)

FDA 510(k)
FDA Class 2 ·General Hospital

Acapella One

FDA UDI
Choice Spine, LP·00840996151146·ACAPELLA,TRIAL,PA,NS,14X18X8

AUTO ENDO5 ML

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code FZP·August 8, 2017

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

CLEARLINK CONTINU-FLO SOLUTION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 6, 2021

CADENCE ZOLL PRECONNECT

FDA Adverse Event
Malfunction ·COVIDIEN·Product code MLN·March 29, 2013

PROSTIVA

FDA Adverse Event
Malfunction ·MPROC, VILLALBA·Product code KNS·April 4, 2011

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·June 13, 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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024