15 results · 19ms · 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.

MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS

FDA 510(k)
FDA Class 2 ·Radiology

GENERUS® II

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K31552991·GENERUS® II Base Rx 022 UL/5-5 CS HK

NEEDLE 30X1/2 RB

FDA Adverse Event
Injury ·BECTON DICKINSON·Product code FMI·August 16, 2025

NEEDLE 30X1/2 RB

FDA Adverse Event
Injury ·BECTON DICKINSON·Product code FMI·August 16, 2025

UROLOGICAL CATHETER

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

TREPCHEK TREPONEMAL ANTIBODY EIA

FDA 510(k)
FDA Class 2 ·Microbiology

PRIME 5TH WHEEL STRETCHER, 30"

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 2, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·March 28, 2011

CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORP.·Product code FPA·April 18, 2008

2710 CLEARTRACE LT

FDA Adverse Event
Other ·CONMED CORPORATION·Product code GXY·April 13, 2007

Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

FDA Enforcement
Class II ·Ongoing·Canary Medical, Inc.·July 16, 2025

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 Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

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