17 results · 20ms · Sources: EU EUDAMED, US FDA

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ABL90 FLEX

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ARGELITE 50 (5 dwt)

FDA UDI
ARGEN CORPORATION, THE·D818120197·Alloy other noble metal

Diversatek Healthcare

FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201970·Basic Endoscopy Procedure Kit

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319703687·Gruenwald (Jansen) Dressing Forceps 6-1/4" (16c...

GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO DATACAPTOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

NEEDLE 22X1 RB

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·July 17, 2024

LUMAX 540 HF-T

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG·Product code NIK·May 20, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 25, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 6, 2011

AMPLATZER AMULET

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code NGV·October 10, 2024

EAGLE EYE PLATINUM SHORT TIP

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant

FDA Enforcement
Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·November 20, 2019

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

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