30 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MINIATURIZE CHEST COMPRESSOR (MCC)
FDA 510(k)
FDA Class 2
·Cardiovascular
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828108621·GEN4 DIGITAL
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828109062·GEN4 DIGITAL
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828113335·GEN4 DIGITAL
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828101899·GEN4 Direct Access
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828101806·GEN4 Direct Access
ProCinch, QuadCinch
FDA UDI
RIVERPOINT MEDICAL, LLC·00840277402950·Adjustable Loop Implant - No Button
VARIANT
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1020680·Trial 26x32mm, 20° Lordotic, 11mm
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020680·SPIRA®-A Integrated,Trial, 28x38mm, 20° Lordoti...
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ORG-9200A
FDA 510(k)
FDA Class 2
·Cardiovascular
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
NORIAN REINFORCED FAST SET PUTTY/3CC
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code GXP·May 19, 2015
VISISTAT 35 R 6/BOX
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GDT·May 3, 2013
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·September 15, 2014
CVC SET: 2-LUMEN 7FR X 2 0CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DQY·April 14, 2011
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·October 15, 2025
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2020
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025