17 results · 27ms · Sources: EU EUDAMED, US FDA

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ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

CoRoent

FDA UDI
Nuvasive, Inc.·00887517362988·CoRoent Small Trial, 8x15x13mm Lord Plus

SILVERCEL

FDA UDI
ADVANCED MEDICAL SOLUTIONS LIMITED·15051978002284·14-24APX Silver Hydro - Alginate

3M™ Silvercel™

FDA UDI
3M Deutschland GmbH·25032749039477·3M™ Silvercel™ Antimicrobial Alginate Dressing,...

0800,APS1,15,N,JW

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828153034·0800,APS1,15,N,JW

Heartline Knot Pusher

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896120907·Heartline Knot Pusher 3 Millimeter Shaft Squeez...

EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD

FDA 510(k)
FDA Class 2 ·Orthopedic

LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DSL-10-2000 ACTIVE® CORTISOL ENZYME IMMUNOASSAY (EIA) KIT

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code CGR·July 21, 2009

UNKNOWN - UNSPECIFIED BY THE COMPLAINANT

FDA Adverse Event
Injury ·COOK BIOTECH, INCORPORATED·Product code PAG·April 3, 2014

ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION

FDA Adverse Event
Injury ·COOK, INC.·Product code MIH·October 16, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007

regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

FDA Enforcement
Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

FDA Recall
Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

ACCOLADE SR SL MRI (Model L310)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025