16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
ONCE TM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Preat
FDA UDI
Preat Corporation·00842092172513·2.5mm Retention Caps--Pink (6-Pack)
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·00840117408524·
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·10840117400891·
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306809699·Luer Lock to Christmas Tree Handle
CUTTER
FDA UDI
Ortho Arch Company Inc·D90980016214·BECK DISTAL END CUTTER - FLUSH CUT
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 23, 1998
METRISCAN BONE DENSITY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
PKG, CROSSFIRE 2 CONSOLE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·February 7, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 17, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007
SMR CTA HUMERAL HEAD Ø46 MM
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code HSD·March 7, 2019
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