18 results · 26ms · Sources: EU EUDAMED, 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