22 results · 32ms · Sources: EU EUDAMED, 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