16 results · 21ms · Sources: EU EUDAMED, US FDA

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DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

Easy Ambulatory

FDA UDI
CADWELL INDUSTRIES, INC.·00840067100455·Easy Ambulatory Recorder

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

AESCULAP- MEITHKE SHUNT SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER

FDA 510(k)
FDA Unclassified ·Unknown

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021

BRAUN

FDA Adverse Event
Injury ·Product code FPA·October 6, 2008

REPLY

FDA Adverse Event
Injury ·SORIN GROUP ITALIA S.R.L·Product code NVZ·June 21, 2013

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 4, 2011

OT VERIO IQ METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 30, 2015

STABLE BASE

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code DRX·December 10, 2019

BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

dS Breast 7ch 3.0T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 4, 2024