16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bernafon
FDA UDI
Bernafon AG·05711584067024·ZR9 MNR T, 2.4G NFM DPB SABE/MAC ZERENA 9
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·August 2, 2016
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO LAPIDUS PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
TRULIANT TIB IMP CRC INSERT SZ 4, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 30, 2022
NAVILYST MEDICAL/BIOFLO
FDA Adverse Event
Injury
·NAVILYST MEDICAL·Product code LJS·October 1, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·June 14, 2013
GENESIS DUAL 4-CHANNEL RECHARGEABLE IPG
FDA Adverse Event
Other
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 6, 2011
PULSE GENERATOR, PERMANENT, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·December 7, 2017
TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 23, 2024
TRULIANT PS CEM FEM PS CEM LEFT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 19, 2022
ADVANCED PATELLA 29M 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
TRULIANT PS CEM FEM PS CEM RIGHT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 19, 2022
Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024