20 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Straumann® Dental Implant System ¿ Roxolid® SLA Implants
FDA 510(k)
FDA Class 2
·Dental
HHM
FDA UDI
Oticon A/S·05707131283115·H110V2, MINIBTE 312 WL 85 SIL HHM
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095658898·Filter pipette tips, 1000uL long, low retention...
KNEE FUSION NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
THE PL-1064 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD SYRINGE 1ML S/T W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 26, 2024
BD SYRINGE 1ML S/T W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 26, 2024
BD SYRINGE 1ML S/T W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 26, 2024
BD SYRINGE 1ML S/T W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 26, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 6, 2013
HIP HEAD, 10/12 TAPER, 28MM, +5MM
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWY·June 29, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
NESTER PLATINUM EMBOLIZATION MICROCOIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
STAINLESS STEEL EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·August 24, 2017
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