13 results · 18ms · 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.

ANTISERA TO HUMAN FAB FRAGMENT

FDA 510(k)
FDA Class 2 ·Immunology

NA

FDA UDI
KEY SURGICAL, INC.·10849771049460·K-Wires, Single diamond, round end, .045-inch (...

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704293142·

K-Wire w. lanzet/round end 1.14mm/229mm, 6 pcs./unit

FDA UDI
mahe medical gmbh·EMAHKM712420·K-Wire w. lanzet/round end 1.14mm...

mahe medical GmbH

FDA UDI
mahe medical gmbh·04050659484610·K-Wire w. lanzet/round end _x000D_...

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515201750·Chandler MIS Retractor, 3/4" wide, 8 5/8"

Symmetry Aufranc

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482125755·Symmetry® Retractor, Aufranc Cobra, 10 mm Serra...

DBEST ONE STEP OCCULT BLOOD TEST KITS

FDA 510(k)
FDA Class 2 ·Hematology

Alma LipoFlow System

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

MAXISKY 600

FDA Adverse Event
Malfunction ·ARJOHUNTLEIGH MAGOG INC·Product code FSA·January 14, 2014

COAGUCHEK XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·February 15, 2008

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2015

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021