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

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SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Bur PM2-70 80K Carb Ø4.0 St

FDA UDI
Bien-Air Surgery SA·17630055503654·

TMA - Archwire

FDA UDI
ORMCO CORPORATION·00889989027020·TMA BROAD ARCH UP SML 0175 0175 PK/10

OsteoMed

FDA UDI
OSTEOMED LLC·00845694028448·ISO Chin Plate, 8mm

Dynamic Axial Fixator

FDA UDI
ORTHOFIX SRL·18033509856082·DRILL BIT D.1,6 MM L.90 MM TIN COATED - QUICK C...

NA

FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604918·Rod Holding Forceps Ø4.5-6.0mm

VAPOTHERM, MODEL 2000I

FDA 510(k)
FDA Class 2 ·Anesthesiology

TRI-PLEX ADAPTER

FDA 510(k)
FDA Class 2 ·Anesthesiology

ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01

FDA 510(k)
FDA Class 2 ·Orthopedic

ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01

FDA 510(k)
FDA Class 2 ·Immunology

ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01

FDA 510(k)
FDA Class 2 ·Immunology

EVIS EXERA II COLONOVIDEOSCOPE

FDA Adverse Event
Injury ·AIZU OLYMPUS CO., LTD.·Product code FDF·November 20, 2024

MAMBA? FLEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025

FLOGARD

FDA Adverse Event
Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·May 8, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 18, 2014

8800

FDA Adverse Event
Malfunction ·GE MED SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·May 13, 2011

PIRANHA

FDA Adverse Event
Injury ·RICHARD WOLF GMBH·Product code JCX·January 5, 2022

Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300

FDA Recall
Terminated ·Aspen Surgical Products, Inc.·Product code CCX·July 23, 2021

Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300

FDA Enforcement
Class II ·Terminated·Aspen Surgical Products, Inc.·September 8, 2021

Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021