20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STAR 90
FDA 510(k)
FDA Class 2
·Cardiovascular
MONOPOLY/CONKLUSION
FDA UDI
SIGNUS Medizintechnik GmbH·04047844039977·The CONKLUSION Pedicle Screw System is a spinal...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100066·TEMPORAL SPECULUM CLOSED WIRE
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100165·KRATZ-BARRAQUER SPECULUM SMALL
Sklar
FDA UDI
SKLAR CORPORATION·30649111092682·SOLUTION BOWL 7 QT PACK OF 12
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613154020164·Posterior Stabilized Tibial Insert
NOBELPROCERA IPS E.MAX CROWN
FDA 510(k)
FDA Class 2
·Dental
STRYKER LOCKED PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code MMI·May 22, 2012
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 13, 2026
ALERE DETERMINE HIV-1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ORGENICS LTD·Product code MZF·February 29, 2016
ALERE DETERMINE HIV-1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ORGENICS LTD·Product code MZF·December 7, 2015
ALERE DETERMINE HIV-1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ORGENICS LTD·Product code MZF·December 7, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
HYDROTHERMABLATOR PROCEDURE SET
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MNB·September 5, 2008
COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHE
FDA Adverse Event
Injury
·COOK INC·Product code DQO·June 23, 2011
RINGLOC-X E1 H/W 56/32MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·April 11, 2025
MISAGO RX Self Expanding Peripheral Stem
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 7, 2016
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