72 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FilmArray BCID2 Control Panel M416
FDA 510(k)
FDA Class 2
·Microbiology
Paradigm
FDA UDI
Proprio, Inc.·00850042604144·Paradigm General Instrument Case Assembly
ReLine
FDA UDI
Nuvasive, Inc.·00195377046932·RELINE-O Trial, 6mm H Lamina W L-pop
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399000897·SMALL SAGITTAL SAW BLADE, 10.2mm X 13.7mm X 0.5mm
OptumSI Implant System
FDA UDI
SI Solutions, LLC·00850057247060·Dilator
Zavation
FDA UDI
Zavation LLC·00842166131583·Ti3Z CIF 12mmx14mmx10mm -0 deg
IRIS SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083455·IRIS SCISSORS SHARP STRAIGHT BLADE POWER CUT GOLD
eWave 6-Lead EKG
FDA UDI
Wearlinq, Inc.·K00010·Continuous wearable electrocardiogram (ECG) mon...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694010795·1.3mm Pilot Drill, J-Latch
NA
FDA UDI
STERILMED, INC.·10888551001533·SAW BLADE SAGITTAL
NA
FDA UDI
STERILMED, INC.·10888551039369·DRILL BIT TWIST
Small Cannulated Countersink AO 125mm
FDA UDI
Osteocentric Technologies, Inc.·00810074306232·Small Cannulated Countersink AO 125mm
Multi-Pump Mounting System Compatible with IPS- B Kit
FDA UDI
EITAN MEDICAL LTD·17290109154081·
Multi-Pump Mounting System Compatible with IPS- B Kit M
FDA UDI
EITAN MEDICAL LTD·17290109154128·
HORIZON DISPLAY CONTROLLER PART # 266-200-010
FDA 510(k)
FDA Class 2
·Cardiovascular
HDL CHOLESTEROL (HDLX) ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
OSTEO-MED
FDA Adverse Event
Malfunction
·OSTEOMED, LP·Product code HTW·April 28, 2005
XTRAFIX BAR TO PIN CLAMP
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KTT·November 10, 2016
XTRAFIX BAR TO PIN CLAMP
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KTT·November 10, 2016