15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REPROCESSED TROCARS AND CANNULAS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sharper Image
FDA UDI
Merchsource, LLC·00843479126945·
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00126441·
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 9, 2026
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
FDA 510(k)
FDA Class 1
·General Hospital
RADIAL HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·December 22, 2023
BARD PARKER
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, INC.·Product code GES·February 22, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011
PUMP MMT-522WWS PRDGM INSULIN SK EN ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED- REL·Product code LZG·March 11, 2008
REUSE PATIENT SET FMS 24PK
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HRX·March 5, 2025
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
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020