15 results · 21ms · Sources: EU EUDAMED, US FDA

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SYNGO MR 2002B

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO TSRH SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ZAP DUAL CURING LIGHT

FDA 510(k)
FDA Class 2 ·Dental

NA

FDA UDI
STRYKER CORPORATION·04546540078438·9.1mm x 7.9mm Fluted Drum

NA

FDA UDI
STRYKER CORPORATION·04546540079480·9.1mm x 7.9mm Fluted Drum

NA

FDA UDI
STRYKER CORPORATION·04546540346216·9.1mm x 7.9mm Fluted Drum

NA

FDA UDI
STRYKER CORPORATION·04546540373205·9.1mm x 7.9mm Fluted Drum

10.5MM X 10.7MM FLUTED DRUM SUPER LONG

FDA Adverse Event
Malfunction ·STRYKER IRELAND LTD.·Product code HBF·May 14, 2009

GORE® EXCLUDER® AAA ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·June 11, 2015

VASOVIEW HEMOPRO 2

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·March 20, 2013

SPRINT QUATTRO SECURE

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC·Product code KWP·March 28, 2008

Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

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