17 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUGLIDE® Disposable Blade
FDA UDI
Technolas Perfect Vision GmbH·04050555000976·Disposable blades for HANSATOME® Microkeratome.
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690736·Titanium Anatomic Angulated Concave Abutment In...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933721·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933110·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955934339·Percutaneous Transluminal Angioplasty Balloon C...
PERSONA® Persona SoluTion™
FDA UDI
Zimmer, Inc.·00889024231740·
PERSONA® Persona SoluTion™
FDA UDI
Zimmer, Inc.·00889024231733·
SHIFENG SYRINGES AND NEEDLES FOR IMMUNIZATIONS
FDA Adverse Event
Malfunction
·CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD.·Product code FMI·February 6, 2023
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RITA STARBURST XLI ELECTROSURGICAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MESH, SURGICAL
FDA Adverse Event
Injury
·W. L. GORE AND ASSOCIATES, INC.·Product code FTM·August 12, 2023
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 22, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 26, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·July 3, 2008
ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·February 17, 2017