21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
FDA 510(k)
FDA Class 2
·Clinical Chemistry
2.5mm Hex Driver Sleeve
FDA UDI
Osteocentric Technologies, Inc.·00816950028571·2.5mm Hex Driver Sleeve
NA
FDA UDI
Smith & Nephew, Inc.·00885556006931·HIBBS LAMINECTOMY RETRACTOR SINGLE END
Ormco
FDA UDI
ORMCO CORPORATION·00889989028478·SS BROAD ARCH LO SML 0160X0220 PK/10
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
ULMER PHARMACAL CO.
FDA registration
ULMER PHARMACAL CO.·1 product·🇺🇸 United States
Matira
FDA UDI
Kalitec Direct LLC·B07307K1100010·Tray Insert 1, Matira, Arcamed
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857527959·Inserter, Outer Shaft/Handle
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Dental
SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·May 13, 2022
OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code QFG·May 2, 2024
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 1, 2011
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 8, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 6, 2019
PERCEPT
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 14, 2024
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2021