22 results · 23ms · 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.

SPEAC System

FDA 510(k)
FDA Class 2 ·Neurology

StarDental Instrument Solutions

FDA UDI
DENTALEZ, INC.·D7022002760·CLASSIQUE DIA INSTRUMENTS 558-7P

7020 CONNECTORS

FDA UDI
HANS RUDOLPH, INC.·00817136022291·CONN 22ID X 15ID 7020 SERIES

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114278·CHAMBER MAINTAINER 20GA (PK/10)

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112618·BARRON CORNEAL PUNCH 7.5MM

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319742563·Killian-Claus V-Shaped Septum Chisel 6-1/2" (16...

SCANLAN®

FDA UDI
SCANLAN INTERNATIONAL INC·00846159007695·Dennis Aortic Anastomosis Clamp

BALANCE MICROPLASTY BROACH

FDA UDI
Biomet Orthopedics, LLC·00880304458994·

Sure-Vue

FDA UDI
FISHER SCIENTIFIC COMPANY L.L.C.·00613647000298·Sure-Vue Signature Strep A

8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535

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

MPT 24 AND VITAL VIEW 24

FDA 510(k)
FDA Class 2 ·Cardiovascular

EPOLY 36MM RLC LNR +5 SZ23

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·February 18, 2019

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 17, 2016

AXS VECTA 074 CATH 132CM - CE

FDA Adverse Event
Injury ·STRYKER NEUROVASCULAR-CALIF·Product code QJP·July 24, 2024

11.0 CM LONG ATTACHMENT

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 24, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·July 1, 2013

ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

FDA Enforcement
Class II ·Terminated·Dental EZ Stardental Division·June 19, 2013

Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

FDA Enforcement
Class II ·Terminated·Bayer Corp·June 11, 2014