19 results · 34ms · Sources: EU EUDAMED, US FDA

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NIRVANA A PERSONAL LUBRICANT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Humelock II Cemented Reversible Shoulder

FDA UDI
FX SOLUTIONS·03701037308554·TRIAL HUMERAL CUP 135/145° STANDARD Ø32 +6

RHEAD

FDA UDI
Stryker GmbH·00886385023090·Lateral Stem Trial; Size 4

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154274468·BONE SCREW,CROSS-PIN,MP,SELF-TAPPING

32mm Glenosphere and Humeral Cup

FDA UDI
FX SOLUTIONS·03701037313886·STANDARD TRIAL HUMERAL CUP CUSTOM MADE 135/145°...

HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VENUS BASIC SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EBV-VCA IGG ELISA TEST, MODEL EBG-100

FDA 510(k)
FDA Class 1 ·Microbiology

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 18, 2020

BD VACUTAINER® SST¿ TUBE 13X75MM, 3.5 ML

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 27, 2017

BD VACUTAINER® PLUS PLASTIC SST TUBE, GOLD BD HEMOGARD¿ CLOSURE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 30, 2017

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

STRETCH LATEX FREE TOURNIQUET

FDA Adverse Event
Other ·HYGENIC CORP.·Product code GAX·August 14, 2008

BD NEXIVA

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 10, 2024

KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

ValueLine Mat Platform Model C2230A,B,C; C922-30A, B,and C; C6904, C6903, C6902, C6901. All tables have the standard platform and the model numbers represent the additional shelves or drawers and the arrangement.

FDA Recall
Terminated ·SAMMONS PRESTON ROLYAN·Product code INT·January 25, 2006

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022