20 results · 21ms · Sources: EU EUDAMED, US FDA

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LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM

FDA 510(k)
FDA Unclassified ·Unknown

ARGEDENT 52SF SPEC (5 dw

FDA UDI
ARGEN CORPORATION, THE·D818120181·Gold based noble metal

Diversatek Healthcare

FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201810·Endoscopy Basic Procedure Kit

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197539944·Mini-Cushing Laminectomy Ronguer downwar ds ang...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197032186·Potts-Smith vascular scissors 19 cm,...

NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS

FDA 510(k)
FDA Class 2 ·Cardiovascular

INDEPENDENCE SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 3, 2023

IN00087 CLERMONT FERRAND PH

FDA Adverse Event
Death ·SORIN GROUP ITALIA·Product code DWF·March 7, 2014

INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016

ANIMAS INSULIN INFUSION PUMP

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

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 25, 2014

EXPEDIUM 5.5 PEEK, PRELORDOSED ROD

FDA Adverse Event
Injury ·DEPUY SPINE, INC.·Product code NQP·June 6, 2011

INSPIRE 6F HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 21, 2022

ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 17, 2025

INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·June 8, 2016

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

FDA Enforcement
Class II ·Ongoing·Auris Health, Inc·February 25, 2026

MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

FDA Enforcement
Class II ·Terminated·Medrad Inc·February 27, 2013

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

IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

FDA Enforcement
Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015