18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Mini-Taurus
FDA UDI
Rmo, Inc.·00885797100757·ALEX MT 022 HK MAX/3 5-5 20EA
HHM
FDA UDI
Oticon A/S·05707131357427·G300 SC, MINIRITE R LI-ION 2.4G C079 HHM
NA
FDA UDI
Synthes GmbH·10886982142566·2.4MM CORTEX SCREW 3.5MM HEAD/SELF-TAPPING 40MM
CODMAN
FDA UDI
Cerenovus, Inc.·10886704001690·CODMAN SLIM-LINE Aneurysm Clip Straight Blade L...
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
FDA 510(k)
FDA Class 2
·Anesthesiology
PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
INNOVA¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIP·April 13, 2016
REPLY
FDA Adverse Event
Injury
·SORIN GROUP ITALIA S.R.L.·Product code NVZ·June 28, 2013
SCREW-IN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code ILS·October 27, 2014
UNK - NAILS: UNIVERSAL NAIL
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·September 22, 2022
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Death
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·June 24, 2016
HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·August 9, 2018
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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025