25 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TRAUMACAD 1.2
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776178819·Goodwin Sound Open Tip fr
Bard® Goodwin Sound
FDA UDI
C. R. Bard, Inc.·00801741047244·Bard Goodwin Sound Open Tip 16 Fr.
Entuit Thrive LP
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356597·
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
FDA 510(k)
FDA Unclassified
·Unknown
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WATCHPAT100
FDA Adverse Event
Injury
·ITAMAR MEDICAL LTD.·Product code MNR·November 12, 2007
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008
CONTOUR THREAD
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 15, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 12, 2013
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAP·September 16, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·September 23, 2009
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·May 15, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Injury
·SURGICAL SPECIALITIES CORP·Product code GAW·February 25, 2014
GLUCOCARD 01 BLOOD GLUCOSE SYSTEM
FDA Adverse Event
Injury
·ARKRAY, INC.·Product code NBW·April 9, 2013
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·March 30, 2011
FLEXTEND IS-1 BI POSITIVE FIX
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)·Product code GAW·October 22, 2009
STERRAD® NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 20, 2018
PKG, 3MM INSERT, FUNDUS GRASPER, 29CPKG, 3MM INSERT, ALLIGATOR GRASPER, 29CM, P/N 0250282051 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014