33 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00
FDA 510(k)
FDA Class 2
·Cardiovascular
Signature
FDA UDI
SILEX MEDICAL, LLC·B33158640000·Atraumatic Grasper
Signature
FDA UDI
SILEX MEDICAL, LLC·B331586400045·Long Locking Gall Bladder Grasping Forceps
Sphere Introducer
FDA UDI
KATENA PRODUCTS, INC.·00841668110836·CARTER SPHERE INTRODUCER
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964091247·The ENDO CARRY-ON Procedure Kit contains all of...
UniTip Catheter
FDA UDI
Unisensor AG·07640172971833·
TANDEM VISUAL HCG IMMUNOENZYMETRIC
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RIONET HEARING AID HB-73
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NA
FDA UDI
Zimmer, Inc.·00889024024403·
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008
Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.
FDA Enforcement
Class II
·Ongoing·Silex Medical, LLC·June 11, 2025
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 11, 2010
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 10, 2012
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 10, 2014
Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.
FDA Recall
Open, Classified
·Silex Medical, LLC·Product code GEI·January 9, 2024
ARCOS 19X190MM SPL TPR DIST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 14, 2018
TI LOW PROFILE SCREW 6.5X50MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 13, 2018
TI LOW PROFILE SCREW 6.5X50MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 13, 2018
FREEDOM CONSTR. LINER +5 SZ 24
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWZ·March 13, 2018