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

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BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B

FDA 510(k)
FDA Class 2 ·Microbiology

Chemosite

FDA UDI
Covidien LP·10884521099272·Catheter Introducer Kit

ACRY PLUS EVO RX

FDA UDI
DENTAL MANUFACTURING SPA·08056865012490·ACRY PLUS EVO RX 8 UPPER

BENCO

FDA UDI
BENCO DENTAL SUPPLY CO.·00366975032676·Curved Clear Correct Crown and Collar Scissor 4.5"

OptiMesh Multiplanar Expandable Interbody Fusion System

FDA UDI
SPINEOLOGY INC.·M7403120049·Portal Head

SMS MULTI GLUCOSE CONTROL, MODEL 2120049

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197028011·Mayo -Noble Scissors curved...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197028004·Mayo-Noble Scissors curved...

FORTAFLEX SURGICAL MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TROJAN PLEASURE PACK LUBRICATED CONDOMS

FDA Adverse Event
Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014

2520274-2013-02717

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·May 20, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·September 25, 2014

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 26, 2011

Auto Suture ChemoSite Catheter Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120049

FDA Recall
Terminated ·United States Surgical·Product code FOZ·May 22, 2006

GALAXY G3 MINI 2MM X 4CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

GALAXY G3 5MM X 15CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

GALAXY G3 MINI 3MM X 8CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.

FDA Enforcement
Class II ·Terminated·Nidek Inc·September 7, 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