21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SofWave System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
iTero Element 2 Plus, cart configuration
FDA UDI
Align Technology, Inc.·00816063020684·Scanner, cart configuration
REUSABLE CUTANEOUS ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
JOULE CLEARSENSE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MYSPINE UNILATERAL LEFT GUIDE S01
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024
MONARCH PLATFORM
FDA Adverse Event
Injury
·AURIS HEALTH, INC.·Product code EOQ·September 6, 2022
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·October 21, 2008
EPIMED RACZ CATHETER
FDA Adverse Event
Malfunction
·EPIMED·Product code BSO·August 9, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 8, 2013
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 18, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·May 20, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·June 10, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 13, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 12, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024
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 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