21 results · 22ms · Sources: EU EUDAMED, 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