19 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Zeramic Adhesive Resin Cement
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699533·GENUMEDI PSS BLUE, SIZE I
TIBIAL INSERT IMPACTOR TIP
FDA Adverse Event
Malfunction
·CONFORMIS, INC.·Product code OOG·April 28, 2017
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100172·KRATZ WIRE SPECULUM WITH WINGS
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383507356·Gutta Percha Points is used to root canal filin...
B-P TOTAL SHOULDER SYSTEM
FDA UDI
ENDOTEC, INC.·00814193025487·B-P SHOULDER HUMERAL HEAD EXTENSION W/ULTRACOAT...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197456326·OESCH Phlebectomy hook
Fig. 1...
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171029533·PESSARY, SHAATZ #5, 2.75"
SENTINELLA 102
FDA 510(k)
FDA Class 1
·Radiology
SMARTDOP 45 VASCULAR DOPPLER
FDA 510(k)
FDA Class 2
·Cardiovascular
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 20, 2025
HAKIM PROGRAMMABLE VALVE
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·June 6, 2013
UNKNOWN DURACON RIGHT KNEE IMPLANT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code JWH·June 23, 2011
INTERSTIM
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 5, 2008
NUTRILINE TWINFLO
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·June 8, 2024
NUTRILINE TWINFLO
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·June 8, 2024
ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PSD-10M, PSD-10CMO3, PSD-10APO-300; ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300; ProScreen 11 Panel Dip Card, Item No. PSD-11MT; ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU; ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP; ProScreen 12 Panel Dip Card, Item No. PSD-12BUP ProScreen 5 Panel Dip Card, Item No. PSD-5MB; ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300; ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU; ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU; ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300, PSD-6MB, PSD-6BUPO; ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M; ProScreen 8 Panel Dip Card, Item No. PSD-8P; ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P; ProScreen 9 Panel Dip Card, Item No. PSD-9P; ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W; ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W; ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W; ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W, PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300; ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W; These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021