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.

SPIROSOFT

FDA 510(k)
FDA Class 2 ·Anesthesiology

Q-RAD System

FDA UDI
CARESTREAM HEALTH, INC.·60889971031198·Q-RAD SYSTEM/QG-6500-3-R10-T920V

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0311930·Probe, 1.75 inch, Egg, Steffee, Long, Curved

STERICHEK TOTAL CHLORINE REAGENT STRIPS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

UNIMARK HCG COMBO PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MARKERS

FDA Adverse Event
Malfunction ·PRAXIM·Product code HAW·January 3, 2007

AED PLUS

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 4, 2013

BRAVO PH MONITORING SYSTEM AND ACCESSORIES

FDA Adverse Event
Malfunction ·GIVEN IMAGING LTD.·Product code FFT·March 17, 2011

ZENITH AAA ILIAC LEG GRAFT

FDA Adverse Event
Injury ·COOK, INC.·Product code MIH·April 16, 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

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016