25 results · 20ms · Sources: EU EUDAMED, 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