18 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUANTA LITE CCP ELISA
FDA 510(k)
FDA Class 2
·Immunology
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154184188·Bone Screws, Cross-Pin
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717104091·Stainless Steel K Files (Hand), Size # 15, Leng...
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221092717·Mini Uni-Twin(TM) Bracket APC(TM) PLUS Sondhi U...
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221061690·Mini Uni-Twin(TM) Bracket APC(TM) II Sondhi UR2...
FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.
FDA Enforcement
Class II
·Terminated·Monteris Medical Corp·November 26, 2014
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113249·PS Insert, Size 4 x 14mm
MEDISUL DISPOSABLE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
FDA 510(k)
FDA Class 2
·General Hospital
BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE)
FDA Adverse Event
Malfunction
·STRYKER LEIBINGER-FREIBURG·Product code JEY·April 29, 2015
3004753838-2018-020414
FDA Adverse Event
Malfunction
·February 27, 2018
EASYPUMP: LT 270-54:270ML, 5ML/HR
FDA Adverse Event
Malfunction
·I-FLOW, LLC,·Product code MEB·October 24, 2014
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 31, 2007
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013
HUT EXT DR FINAL ASSY-REVERSE
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·February 8, 2011
ARTERIAL CANNULA FOR SMALL CHILDREN, 6MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·July 3, 2020
BONE SCREWS, CROSS-PIN, DIAM.2.0X16MM, (5/PACKAGE)
FDA Adverse Event
Malfunction
·STRYKER LEIBINGER FREIBURG·Product code JEY·May 24, 2018
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012