11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Acne Light Therapy Wand
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500
FDA 510(k)
FDA Class 2
·Radiology
EASY X-TRAC SYSTEM
FDA 510(k)
FDA Class 1
·Dental
INSYTE AUTOGUARD
FDA Adverse Event
BECTON DICKINSON·Product code FOZ·September 5, 2012
ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code KWP·August 23, 2017
MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·December 13, 2022
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 7, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANLDE AND HAND CONTROL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 5, 2008
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024