21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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A & I WHEELCHAIRS
FDA 510(k)
FDA Class 1
·Physical Medicine
Ormco
FDA UDI
ORMCO CORPORATION·00889989062977·CAP REMOVER KIT
Elite Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7403010094·8mm Paddle Distractor
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100040·Tap, 5.5mm Cann, Quarter Square
TiWave C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07320K0100040·Draw Rod, Inserter
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0100040·Caddie, Screws
SIMPLY SPECS
FDA UDI
FGX INTERNATIONAL INC.·00193033091524·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0100040·Inserter Draw Rod, InTess C
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100240·SNII Tap, 4.50mm
Matira
FDA UDI
Kalitec Direct LLC·B07307K0100240·Assembly, Caddie, Screws, Hinged
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100240·Caddie, Fixed Cross Links, 5.5mm, Assesmbly
SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 16, 2011
AXSYM DIGOXIN III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 11, 2011
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·January 28, 2023
GALAXY G3 3MM X 8CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014