15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CREATION CP-ZI PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
Vial Adapter
FDA UDI
WEST PHARMA. SERVICES IL, . LTD·07290108240887·Vial Adapter 13mm FLL SIL- VF
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704507249·
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695199·Wide Implant Drill Kit
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695243·Titanium Base Abutment Internal Hex. NP H3mm En...
LifeBand® Load-distributing Band
FDA UDI
Zoll Circulation, Inc.·00849111002219·Single-use chest compression band. (1 per pack...
ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)
FDA 510(k)
FDA Class 2
·Ophthalmic
RS-4M+MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 17, 2025
CARTRIDGE
FDA Adverse Event
Injury
·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015
CUSA EXCEL 23KHZ CEM NOSECONE
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES (IRELAND) LIMITED·Product code LFL·April 15, 2013
ARCHITECT HAVAB IGM REAGENT
FDA Adverse Event
Malfunction
·ABBOTT·Product code LOL·April 27, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 3, 2008
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015