13 results · 36ms · 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.

TOTAL PARENTERAL NUTRITION SET BAG

FDA 510(k)
FDA Class 2 ·General Hospital

Symmetry WILLIAMS

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031315·Symmetry® Retractor, Williams Microlumbar, 70 m...

ACUMED

FDA UDI
Acumed LLC·10806378050695·Drill Guide/Trial Assembly 17mm

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776098087·Spinal Discectomy Retractor

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135257·

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776098117·Spinal Discectomy Retractor

CLAROS NANO DENTAL LASER SYSTEM

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

COBRA-OS Kit

FDA 510(k)
FDA Class 2 ·Cardiovascular

BURR, OVAL, FLUSHCUT, 12 FLUTE, 5.0MM X 13CM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code GFF·May 9, 2014

UNKNOWN DEPUY ASR ACETABULAR CUP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 7, 2007

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 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