11 results · 20ms · Sources: EU EUDAMED, US FDA

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FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM

FDA 510(k)
FDA Class 2 ·Cardiovascular

SCS DT-02 TRANSVERSE CONNECTOR

FDA 510(k)
FDA Class 2 ·Orthopedic

XIA SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

KYPHX® HV-R? BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code NDN·March 14, 2014

KYPHX® HV-R? BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code NDN·June 20, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 6, 2013

ASR ACETABULAR CUPS 62

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 12, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 5, 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

StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - 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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018