251 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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CAMLOG ROOTFORM IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317319869·
Impella
FDA UDI
Abiomed, Inc.·00813502012828·Impella 5.5 with Smart Assist S2 Set, US
eWave 6-Lead EKG
FDA UDI
Wearlinq, Inc.·K00010·Continuous wearable electrocardiogram (ECG) mon...
SELF-RETAINING ELECTRODE SER. #4000-100
FDA 510(k)
FDA Class 2
·Cardiovascular
SurgiTouch™ Scanner
FDA UDI
LUMENIS LTD.·07290109142203·
ALINITY C CALCIUM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code CJY·November 24, 2021
OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
microdot®
FDA UDI
Cambridge Sensors USA LLC·00847713000572·microdot® Pulse Oximeter
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399000705·PNEUMATIC MOTOR MODULE, MICROAIRE CONNECTOR
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776157265·Malis type Bipolar Forcep, bayonet, non-insulat...
Graft Delivery System
FDA UDI
ALPHATEC SPINE, INC.·00190376544588·Graft Delivery Tube
TruFlex™
FDA UDI
Ortho Organizers, Inc.·00190707125103·TRUFLEX NiTi U/L .012 (10pk)
TruFlex
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730011725·NiTi U/L .012 10 archwires per pack
PLATE TRYPTICASE SOY AGAR 5% SB 100 EA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·October 26, 2022
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JOBST Confidence
FDA UDI
BSN-Jobst GmbH·04059993564545·CONFIDENCE 2/CAPRI PANTY B1T W. BODY BANDAGE/FO...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702260649·ELVAREX 4 SUPER/THIGH HIGH/OPEN TOE/DOTTED 5 CM...
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555102000100·Curved Rod 6.0mm, 100mm