24 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SILK, NONABSORBABLE, SURGICAL SUTURES, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Leksell Stereotactic System
FDA UDI
Elekta Instrument AB·07340048305266·ARC ATTACHMENT FOR COUNTER SCALE
Coagulation RF cable
FDA UDI
ATRICURE, INC.·10840143901485·
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001184·artVeneer life upper anteriors, ITS, B1
Diagon
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030MO0011840·15°, 12mm x 39mm x 16mm Oblique ASM
AUDIOSCREENER OAE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TRANS FX ADJUSTABLE PIN TO BAR CLAMP
FDA 510(k)
FDA Class 2
·Orthopedic
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·June 21, 2023
HERO GRAFT
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code DSY·August 3, 2015
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·February 11, 2025
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·March 8, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code MCX·February 24, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2008
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD·Product code QKP·February 26, 2024
HERO GRAFT
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code DSY·July 31, 2015
HERO GRAFT
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code DSY·August 3, 2015
HERO GRAFT
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code DSY·June 15, 2015
HERO GRAFT
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code DSY·June 15, 2015
HERO GRAFT
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code DSY·June 9, 2015
Xhibit Telemetry Receiver, Model: 96280
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022