27 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EMM EQUIPMENT COVER-POLYTHYLENE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sklar®
FDA UDI
SKLAR CORPORATION·10649111367861·MAYO TRAY PERF211/4X161/4X7/8"
Sklar®
FDA UDI
SKLAR CORPORATION·30649111268032·MAYOTRAYPERF211/4X161/4X7/8PK6
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 24, 2024
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·June 10, 2024
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·April 18, 2024
XEN 45 GTS
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·November 9, 2022
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 20, 2024
XEN 45 GTS
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·November 9, 2022
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2013
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON ¿ IRVINE TECHNOLOGY CENTER·Product code HQC·September 15, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 11, 2011
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
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
FDA Enforcement
Class II
·Ongoing·GE Healthcare·November 1, 2023
Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System
FDA Enforcement
Class II
·Ongoing·GE Healthcare·May 10, 2023
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024