25 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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