25 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101080·Distractor, Smooth Paddle, 8mm
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101080·Distractor, Smooth Paddle, Lordotic, 8mm
USS-LINE EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
BenaCel
FDA UDI
UNICARE BIOMEDICAL INC.·D767B0101081·BenaCel® dental dressing is made of biocompatib...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540246356·Drill, WL 8mm, Stryker Shaft
Minuteman
FDA UDI
Spinal Simplicity, LLC·M9432000101080·Speed Adaptor, 8mm
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C30430101080·PEEK PLIF Spacer, 30 x 10 x 10mm, 8 deg
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C31430101080·Titanium PLIF Spacer, 30 x 10 x 10mm, 8 deg
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100080·Dilator Sleeve, Probe
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971123·
PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
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
OT PING METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 1, 2011
DISPOSABLE PET BALLOON DILATORS
FDA Adverse Event
Malfunction
·JUAREZ FACILITY·Product code KNQ·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
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·September 6, 2023