12 results · 21ms · 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.

ZODIC POLYAXIAL SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014609942·MIDMARK 3.25" SOFTCARE PLUS

SWIFT 2.0, MODEL 132.001

FDA 510(k)
FDA Class 2 ·Radiology

ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

CADD MEDICATION CASSETTE

FDA Adverse Event
Malfunction ·NULL·Product code FPA·February 4, 2022

SMARTSET MV 40G - EO

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LOD·October 18, 2019

UNKNOWN DEPUY ASR ACETABULAR CUP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 26, 2013

ACCURUS 400VS

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 14, 2011

MINILOC

FDA Adverse Event
Malfunction ·BARD ACCESS SYSTEMS·Product code FMI·July 9, 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

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025