22 results
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23ms
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Sources: EU EUDAMED, US FDA
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