23 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEUTROPHASE
FDA 510(k)
FDA Class 1
·General Hospital
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380076275·0.8mm Guide Wire 100mm
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608891·MIDMARK 2.25" DELUXE GEL
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310090·Probe, 1.5 inch Ball, Lenke, Thoracic, Curved, ...
Baby Gorilla/Gorilla Plating System
FDA UDI
Paragon 28, Inc.·00889795034526·Gorilla, Posterolateral, Fibular, 09-Hole, w/Co...
RANDOX C-REACTIVE PROTEIN
FDA 510(k)
FDA Class 2
·Immunology
WHITE MTA MATERIAL
FDA 510(k)
FDA Class 2
·Dental
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 29, 2024
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 16, 2025
WAVEWRITER ALPHA PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 5, 2023
AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·May 30, 2023
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 24, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 9, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2011
AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 25, 2022
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 22, 2011
AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 20, 2023
HOSP SS FLEXX METER W/O LASER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 17, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Death
·LIFESCAN INC.·Product code NBW·April 1, 2011
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018