45 results
·
23ms
·
Sources: EU EUDAMED, US FDA
DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S
FDA 510(k)
FDA Class 2
·Dental
Bur PM2-70 50K Diam Ø0.8
FDA UDI
Bien-Air Surgery SA·07630055502247·
ARGENCO W-LITE
FDA UDI
ARGEN CORPORATION, THE·D818100248·Alloy other noble metal
MAYO SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046825·MAYO SCISSORS STRAIGHT BEVELED BLADES
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828101318·GEN4 INTERACTIVE
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828120210·GEN4 INTERACTIVE
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828133586·GEN4 INTERACTIVE
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828115537·GEN4 INTERACTIVE
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828107587·GEN4 Direct Access
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319736241·Potts-Smith Scissors 7-1/2" (18.8cm), angled on...
CARTO EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
E1 ANTIOXIDANT INFUSED TECHNOLOGY
FDA 510(k)
FDA Class 2
·Orthopedic
PHYSICA KR LINER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code MBH·December 20, 2022
SMR HUMERAL HEAD Ø48 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·January 27, 2023
QUANTUM MAVERICK MONORAIL BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·February 7, 2007
MESH, SURGICAL, POLYMERIC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 18, 2014
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code MMI·May 24, 2011
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 12, 2015
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·December 31, 2014