16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CALCIUM SULFATE PELLETS
FDA 510(k)
FDA Class 2
·Orthopedic
Implant Prosthetics
FDA UDI
Preat Corporation·00842092118320·Straumann® BL-compatible NC X 4.5mm Non-Engagin...
Preat
FDA UDI
Preat Corporation·00842092170793·Straumann® BL NC-compatible Non-Engaging Ti Bas...
PIC Plus
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783000191·PIC Plus Sample - White
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001559·artVeneer life lower anteriors, UIM, BL1
HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NORMOCARB STERILE BICARBONATE RENAL DIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WAVEWRITER ALPHA? PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 30, 2026
UNKNOWN MICROCATHETER
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·October 15, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 30, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·March 13, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·February 21, 2008
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018