21 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SILKRO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOBUTTON
FDA UDI
Smith & Nephew, Inc.·03596010497000·40 MM ENDOBUTTON CL BTB
Aveta Max Disposable Resecting Device, 3.9 mm
FDA UDI
MEDITRINA, INC.·00850006759323·Aveta Max Disposable Resecting Device, 3.9 mm, ...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319721711·Miller Rake Retractor 5-1/4" (13.1cm), 9 blunt ...
Dilator, Vascular, Memory 20cm 2.5mm alu-handle GREEN
FDA UDI
Geister Medizintechnik GmbH·04057034046241·Dilator, Vascular, Memory
20cm 2...
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
FDA 510(k)
FDA Class 2
·Neurology
ENDOSCOPIC RETRIEVAL DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 3, 2022
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 20, 2022
ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36MM - 15MM ACTIV
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·October 22, 2008
UNKNOWN PRODUCT - SIZE 1 ACCOLADE STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·August 3, 2011
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 8, 2013
INDIGO SYSTEM SEPARATOR 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·September 13, 2022
IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
IM REAMER, AO FITTING BIXCUT Ø7,5X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
IM REAMER, AO FITTING BIXCUT Ø8,5X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·October 13, 2023
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014