18 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Vantage Elan 1.5T, MRT-2020, V6.0
FDA 510(k)
FDA Class 2
·Radiology
Hysteroscopic Fluid Management
FDA UDI
Smith & Nephew, Inc.·03596010529534·HYST FLUID MGMT SYSTEM CONTROL UNIT
Dilator, Vascular, acc. Garrett 35cm 2.0mm
FDA UDI
Geister Medizintechnik GmbH·04057034047538·Dilator, Vascular, acc. Garrett
35cm 2...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706541·Converse Alar Retractor 4" (10cm), double ended...
5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
FDA 510(k)
FDA Class 2
·Orthopedic
ICG MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
TRUCLEAR
FDA Adverse Event
Death
·SMITH AND NEPHEW·Product code HIH·June 3, 2015
GYNECOLOGY CAPITAL
FDA Adverse Event
Malfunction
·OKLAHOMA CITY MANUFACTURING SITE·Product code HIG·August 19, 2011
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 12, 2011
PLUS
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPEDICS AG·Product code KWY·October 23, 2008
SWEET TIP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 8, 2013
NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code LJE·May 28, 2013
NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·July 17, 2013
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 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
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024