24 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HydroMARK Breast Biopsy Site Marker
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Smith & Nephew, Inc.·03596010563279·TFCC MENDER DISPOSABLE SUTURE SYSTEM
Shannon Recta Larga Round Shank
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613289600·
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK
HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
FDA 510(k)
FDA Class 2
·Radiology
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JAW INS. BULLET NOSE GRASPER 5MM 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015
MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014
TFCC MENDER DISPOSABLE SUTURE SYSTEM
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HWQ·August 7, 2020
TFCC MENDER DISPOSABLE SUTURE SYSTEM
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HWQ·August 7, 2020
KARDIAMOBILE
FDA Adverse Event
Malfunction
·ALIVECOR·Product code DPS·January 24, 2022
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·October 23, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
QUADRA ASSURA CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013
TFCC MENDER DISPOSABLE SUTURE SYSTEM
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HWQ·March 1, 2020
TFCC MENDER DISPOSABLE SUTURE SYSTEM
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HWQ·March 1, 2020
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
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021