23 results · 22ms · 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.

GR40CW

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I

n.a.

FDA UDI
Karl Storz GmbH & Co. KG·04048551057728·BUCK Ear Curette. Sharp, Size 1

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100318·ALPHONSO INFANT SPECULUM

Anatotemp

FDA UDI
BUCKEYE MEDICAL TECHNOLOGIES, LLC·D7861534010·Anatotemp Anatomic Dental Implant Healing Abutm...

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100356·COOK EYE SPECULUM #1 SOLID

STINGRAY LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ORTHO-1(NOT FINALIZED)

FDA 510(k)
FDA Class 2 ·Dental

NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code MCM·September 26, 2019

STINGRAY? LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

ACCU-CHEK ® COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 13, 2010

SPRINT QUATTRO

FDA Adverse Event
Injury ·MPRI·Product code LWS·June 8, 2013

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 8, 2014

RADIAL JAW 3 HOT BIOPSY FORCEPS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KGE·August 21, 2008

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code MMI·April 15, 2010

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CEM·April 5, 2010

Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

FDA Enforcement
Class II ·Ongoing·Canary Medical, Inc.·July 16, 2025

Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·April 13, 2022