122 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CELFIRM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
External Fixation
FDA UDI
Life Spine, Inc.·00190837023027·Slotted Washer
X-Wing Alignment Rod
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076450·
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C
FDA 510(k)
FDA Class 2
·Radiology
ELLIPSE JUVIA, MODEL 9EJU7465
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SANTORINI Corpectomy Cage System
FDA UDI
VB Spine LLC·10888857243170·Bone Funnel Pusher
MEDFUSION
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·January 19, 2022
UNKNOWN HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·February 2, 2018
UNKNOWN HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2018
UNKNOWN HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2018
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·June 24, 2022
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 10, 2013
M2A MAGNUM TAPER ADAPTER 42-50MM PLUS 3MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 22, 2011
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 18, 2008
UNKNOWN HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·February 2, 2018
UNKNOWN HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·February 2, 2018
PENUMBRA COIL 400
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·November 29, 2016
UNKNOWN HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·February 2, 2018
UNKNOWN HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·February 1, 2018
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·December 29, 2021