20 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Jaeger
FDA UDI
Jaeger Medical GmbH·04250892905310·MasterScreen Pneumo
Jaeger
FDA UDI
Jaeger Medical GmbH·04250892900391·MasterScreen Pneumo
Jaeger
FDA UDI
Jaeger Medical GmbH·04250892900698·MasterScreen Pneumo
Jaeger
FDA UDI
Jaeger Medical GmbH·04250892905334·MasterScreen Pneumo
NC/RC Coping for screw-retained abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600381389·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293487·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049651·Steinmann Pins, Single trocar, 3 shank end, 5/6...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771013051·Steinmann Pins, Single trocar, 3 shank end, 5/6...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484870·Steinmann pin w. trocar/3-shank _x000D_...
Steinmann pin w. trocar/3-shank 2.0mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM714800·Steinmann pin w. trocar/3-shank
2.0mm/...
LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 17, 2008
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 30, 2011
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 9, 2024
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 26, 2024
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021