24 results
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20ms
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Sources: EU EUDAMED, US FDA
Miret Grasper, Alligator, Miret Grasper, Maryland
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Denovo general purpose dental molar band
FDA UDI
Denovo Dental, Inc.·00810059290037·Denovo general purpose dental molar band - Maxi...
Coaxial needle
FDA UDI
Möller Medical GmbH·04260277177904·
SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA
FDA 510(k)
FDA Class 2
·General Hospital
SUNIPAN IMAGING SYSTEM & ACCESSORIES
FDA 510(k)
FDA Class 2
·Dental
PENUMBRA MAX PUMP - INDIGO SYSTEM
FDA Adverse Event
Malfunction
·PENUMBRA INC., USA·Product code NRY·August 23, 2018
PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·March 8, 2018
ADVANTAGE SERIES 29 OBS 10/04
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 10, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 13, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
PENUMBRA SYSTEM ASPIRATION PUMP MAX 220
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·April 9, 2018
BD EMERALD¿ 10ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 26, 2017
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2025
GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·June 23, 2023
GMK-HINGE FEMORAL COMPONENT SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·February 7, 2022
GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2019
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 4, 2019
Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 3, 2013
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022