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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

GLUCOSE-SL-C ASSAY, MODEL 257-30

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496023739·VENERE 70, SIZE XXL, SABBIA, GRADUATED COMPRESS...

SURGIN SURGICAL INSTRUMENTATION, INC.

FDA registration
SURGIN SURGICAL INSTRUMENTATION, INC.·4 products·🇺🇸 United States

MODIFICATION TO EBI XFIX DFS SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ALOKA SSD-4000

FDA 510(k)
FDA Class 2 ·Radiology

ELECTRIC PEN DRIVE 60,000 RPM

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWE·March 27, 2013

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 18, 2011

MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Other ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·March 31, 2008

THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·November 1, 2023

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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018