14 results · 24ms · 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.

SYNFIX-LR SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

Australis ALIF Cage

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215127794·

Genius Total Knee System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021955·

SLEEPSENSE SLEEP SENSORS

FDA 510(k)
FDA Class 2 ·Anesthesiology

SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Crescendo Meniscal Insert CR Ultracongruent 11mm Size 3

FDA UDI
AMPLITUDE SAS·03701089524681·

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 19, 2020

RENAL UROLOGY STENT K072293

FDA Adverse Event
Other ·FOSSA MEDICAL INC·Product code FAD·April 10, 2014

QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·July 1, 2016

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·April 23, 2013

SPRINT FIDELIS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 28, 2011

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

FDA Enforcement
Class II ·Terminated·Unomedical As·November 9, 2016

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