9 results · 29ms · 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.

TSH RADIOIMMUNOASSAY KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113509·MINIATURE BLADE #67 (BX/5)

COALIZA PROTEIN S-FREE

FDA 510(k)
FDA Class 2 ·Hematology

ENSITE FUSION DYNAMIC REGISTRATION TOOL

FDA 510(k)
FDA Class 2 ·Cardiovascular

HEARTSTART FRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014

AMBIENT SUPER TURBOVAC 90 WITH IFS

FDA Adverse Event
Malfunction ·ARTHROCARE CORPORATION·Product code GEI·October 18, 2012

RESOLUTION HEMOSTASIS CLIPPING DEVICE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·August 17, 2010

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

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