19 results · 28ms · Sources: EU EUDAMED, US FDA

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PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ARGEDENT 40SF (5 dwt)

FDA UDI
ARGEN CORPORATION, THE·D818120173·Gold based noble metal

Frame Carrier Breast BI 7 meidal

FDA UDI
Noras MRI products GmbH·04251269205637·

Diversatek Healthcare

FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201730·Endoscopy Basic Procedure Kit w/o Suction Tubing

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319720127·Gruenwald (Jansen) Dressing Forceps 7-1/2" (19c...

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 9, 2021

ID NOW COVID-19

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 6, 2020

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QJR·April 6, 2021

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197031776·Davis Facelift Scissors curved...

IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

POWERPACK

FDA Adverse Event
Malfunction ·ICC-NEXERGY·Product code IYN·September 3, 2013

ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

FDA Adverse Event
Injury ·CORDIS CORPORATION·Product code NTE·May 20, 2013

GORE® TAG® THORACIC ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·September 25, 2014

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SHERBROOKE·Product code BRZ·June 10, 2011

POWERED WHEELCHAIR

FDA Adverse Event
Other ·INVACARE·Product code ITI·March 9, 2011

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

EMBLEM S-ICD Model A209

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021