22 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
Bur PM2-70 50K Carb Ø4.5
FDA UDI
Bien-Air Surgery SA·07630055502476·
Dark Star Deformity
FDA UDI
Republic Spine, LLC·B0751002710·Distractor, Double Action
COOLEY TANGENTIAL OCCL CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921002710·COOLEY TANGENTIAL OCCLUSION CLAMP ANGLED JAW AN...
Cooley Tangential Occlusion Clamp
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896108202·Cooley Tangential Occlusion Clamp Double Angled...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319736340·Wagner Plastic Surgery Scissors 4-3/4" (12.1cm)...
LINER: MPACT FLAT PE HC LINER Ø36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 22, 2021
THINKINGNET
FDA 510(k)
FDA Class 2
·Radiology
HARDYDISK, SULFA/TRIMETH
FDA 510(k)
FDA Class 2
·Microbiology
PHYSICA KR LINER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code MBH·December 20, 2022
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024
URISYS 2400
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JIL·May 8, 2013
ABBOTT M2000SP
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code JJH·September 18, 2014
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MMI·May 24, 2011
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·May 24, 2023
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 6, 2023
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 2, 2023
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
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·October 5, 2022