18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Stone Retrieval Balloon
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NuVasive
FDA UDI
Nuvasive, Inc.·00887517949110·Adjustable Pistol Grip XL Inserter
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780454656·Integra® Jarit® Hibbs Retractor, 9-1/4", 19mm W...
DEBAKEY FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896100589·DEBAKEY FORCEPS ROUND HANDLE COUNTER WEIGHT
Initia Total Hip System
FDA UDI
KYOCERA CORPORATION·04547898306877·MX LINER 36-66/70
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457200369·External Hex Universal
Initia Total Hip System
FDA UDI
KYOCERA MEDICAL CORPORATION·04580810058423·"MX LINER 36-66/70
Size:36-66/68/70
Type:Elevat...
ACUMED
FDA UDI
Acumed LLC·10806378013522·2.7mm x 65.0mm Cortical Screw
ACUMED
FDA UDI
Acumed LLC·10806378013539·2.7mm x 65.0mm Cortical Screw
CEMENT IT! UNIVERSAL C&B
FDA 510(k)
FDA Class 2
·Dental
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025
ENPULSE
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code DXY·August 10, 2011
SMALL BATTERY DRIVE
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·October 24, 2014
UNK
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 1, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 8, 2015
ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014