21 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRANSTEK BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197028271·Joseph Dissecting Scissor
straig...
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
MEDICAL LE
FDA 510(k)
FDA Class 2
·Radiology
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 15, 2022
Trilogy®
FDA UDI
Zimmer, Inc.·00889024637672·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024637665·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024361126·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024361133·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024637689·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024361140·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024637658·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024116702·
BAROUK SCREW - 3 0MM X 32MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·April 7, 2020
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 26, 2011
ECHELON FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDW·May 9, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 25, 2014
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
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
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