20 results · 22ms · Sources: EU EUDAMED, US FDA

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CATHETER INTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·H65810435251·Acclean Prophy Paste Coarse

SureLOK Mini Posterior Cervical/Upper Thoracic System

FDA UDI
PRECISION SPINE, INC.·00840019907125·3.5mm x 25mm SureLOK™ PC Screw

VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)

FDA 510(k)
FDA Unclassified ·Unknown

SYSTEM 98XT, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·February 3, 2026

EVIS EXERA III BRONCHOVIDEOSCOPE

FDA Adverse Event
Injury ·AIZU OLYMPUS CO., LTD.·Product code EOQ·May 19, 2023

SYSTEM 98XT

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·September 22, 2025

IBP ELB INT. ULNA LRG RGT LNG STM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JDC·June 24, 2016

ASSY,ENGLISH,DOMSTC,110V,SYS98

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·December 26, 2025

CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·November 3, 2025

CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·November 18, 2025

MAXCEM ELITE

FDA Adverse Event
Injury ·KERR CORPORATION·Product code EMA·April 9, 2013

ISERT ASPHERIC INTRAOCULAR LENS

FDA Adverse Event
Malfunction ·HOYA SURGICAL OPTICS INC.·Product code HQL·February 25, 2011

CONTAK RENEWAL 4

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·January 14, 2026

ASSY,ENGLISH,DOMSTC,110V,SYS98

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·September 15, 2025

SENSATION 7FR. 34CC IAB

FDA Adverse Event
Death ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021

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

Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·November 28, 2018