22 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROFILE II ER
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VIvid NanoFil Refill Syringe BL-2
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724D0101380·
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036006549·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101080·Distractor, Smooth Paddle, 8mm
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C30430101380·PEEK PLIF Spacer, 30 x 10 x 13mm, 8 deg
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101080·Distractor, Smooth Paddle, Lordotic, 8mm
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C31430101380·Titanium PLIF Spacer, 30 x 10 x 13mm, 8 deg
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
FDA 510(k)
FDA Class 2
·Cardiovascular
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE
FDA 510(k)
FDA Class 1
·General Hospital
SCR REPLACEMENT SW-V GOLD COPING
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·October 19, 2017
SCR FIXATION REPLACE SPEC TRA-CONE & TAPERED ABU
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 8, 2020
30 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·February 7, 2019
TRIDENT 10° X3 INSERT 32MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·March 19, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·March 1, 2011
CALAXO 7X25MM REVERSE THREAD SCREW
FDA Adverse Event
Other
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·March 10, 2008
25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016
27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·November 30, 2016
25 G X 5/8 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·February 24, 2017
27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·November 30, 2016
Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.
FDA Recall
Terminated
·Product code HRY·April 22, 2011