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