16 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.

SURGISIS STAPLE LINE REINFORCEMENT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Safco T&F Bur - 12 Bladed

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310220443·Safco T&F bur - 12 bladed, carbide, #7206 taper...

LINK Instruments - Trial implants and size gauges

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575408948·Acetabulum prosthesis trial, reusable - Vario-C...

BD PRECISIONGLIDE NEEDLE 25G X 1 1/2 IN

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 20, 2020

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710410220440·Anterior Closing Wedge Osteotomy Guide, 22mm x ...

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710420220440·Anterio Lateral Closing Wedge Osteotomy Guide, ...

MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT

FDA 510(k)
FDA Class 2 ·Ophthalmic

BI-PHASIC INFILTRATOR

FDA 510(k)
FDA Class 2 ·General Hospital

TITAN TOUCH SCRO ZERO ANG 18CM

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code FHW·August 6, 2018

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC·Product code FRN·January 6, 2025

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·March 26, 2013

SECURE ACUTE CARE BED 3/01

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·March 10, 2011

BD Q SITE EXTENSION SET

FDA Adverse Event
Malfunction ·MPS ACACIA·Product code FPA·March 31, 2008

Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

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 Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014