18 results · 23ms · Sources: EU EUDAMED, US FDA

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BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Arsenal

FDA UDI
ALPHATEC SPINE, INC.·00840967162386·OFFSET THORACIC SUPRALAMINAR HOOK, RIGHT, 7.5mm

True Position® Spacer System

FDA UDI
Spine Wave, Inc.·10840642107715·Implant, 30 (L) x 7.5 (H) mm

True Position®

FDA UDI
ATLAS SPINE, INC.·M68112080230750·30mm x 7.5mm Non-Lordotic Spacer

KNIGHTSTAR 330 VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

FDA 510(k)
FDA Class 2 ·Microbiology

CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM

FDA Adverse Event
Malfunction ·AESCULAP AP & CO. KG·Product code GEI·March 27, 2015

CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO KG·Product code GEI·April 6, 2015

CAIMAN DISP.INSR.ARTICULAT.D:12 / 240MM

FDA Adverse Event
Malfunction ·AESCULAP AG& CO. KG·Product code GEI·April 15, 2015

CAIMAN DISP INSTR ARTICULAT D:12/240MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO KG·Product code GEI·April 16, 2014

ACUITY CENTRAL MONITORING

FDA Adverse Event
Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code DSI·February 27, 2013

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 24, 2011

COLLEAGUE VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008

EVOLUT R TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 6, 2023

CAIMAN DISP. INSTR. ARTICULAT. D.: 12/440MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code GEI·July 28, 2014

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

The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020