18 results · 26ms · Sources: EU EUDAMED, US FDA

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Bone Screws dia. 5,0 mm

FDA 510(k)
FDA Class 2 ·Orthopedic

KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)

FDA 510(k)
FDA Class 2 ·Orthopedic

OTOLARYNGOLOGY BUR (DEVICE 4 OF 4)

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code EQJ·October 23, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

ELLIPSE DR, DF4 CONNECTOR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

BD CATHENA¿ SAFETY IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 19, 2022

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·September 18, 2020

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 23, 2020

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 20, 2021

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 18, 2021

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 20, 2021

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 18, 2021

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·February 25, 2021

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·February 25, 2021

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015