19 results · 23ms · Sources: EU EUDAMED, US FDA

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NC TREK OTW CORONARY DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

5570 3L SYRINGE

FDA UDI
HANS RUDOLPH, INC.·00817136021188·5570 3L SYR-TOURQ, 612735 OUTL

Nautilus

FDA UDI
Life Spine, Inc.·00190837075927·5.5MM ROD BENDER

SCREW,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HWC·June 9, 2017

PACIFIC XTREME PTCA BALLOON DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

LIGACLIP** ENDOSCOPIC CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 15, 2013

ARTICULEZE M HEAD 36MM +12

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code JDI·September 24, 2014

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 25, 2011

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code HWC·June 2, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code HWC·June 3, 2015

ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R

FDA Recall
Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311

FDA Recall
Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R

FDA Recall
Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311

FDA Recall
Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

EMBLEM S-ICD Model A209

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

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

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