14 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.

NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY

FDA 510(k)
FDA Class 2 ·Physical Medicine

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120243101·Carbide - Finishing Burs

APEX Revision Knee

FDA UDI
Omni Life Science, Inc.·00841690114048·PS-R Insert, Size 3 x 10mm

Myo/Wire

FDA UDI
A & E MEDICAL CORPORATION·10841291100256·Temp Pacing Wire

PrimeSight

FDA UDI
SCHÖLLY FIBEROPTIC GmbH·04250480106310·Sinuscope 4 x 175 mm, 0°

DAVLITE MICROENDOSCOPE & ACCESSORIES

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)

FDA 510(k)
FDA Class 2 ·Orthopedic

DEVICE 8252410 NIM-NEURO 2.0 INTERFACE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code IKN·February 21, 2014

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code BTI·March 27, 2013

MEGA SUTURECUT NEEDLE DRIVER

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL·Product code NAY·March 7, 2011

QUANTUM MAVERICK MONORAIL BALLOON CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LOX·April 3, 2008

MERSILENE TAPE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAT·November 4, 2024

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