20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Trivex System
FDA UDI
Lemaitre Vascular, Inc.·00840663106547·Trivex System cart
Kompressor™ Compression Screw System
FDA UDI
Ascension Orthopedics, Inc.·10381780065586·The standard Kompressor Compression Screw is a ...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319707272·Rubin Nasal Lateral Osteotome 8" (20cm), U-shap...
R & D DESIGNATION AP-035
FDA 510(k)
FDA Class 2
·Dental
QLAB 8.1 QUANTIFICATION SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
DEPTHALON®
FDA UDI
PMT CORPORATION·00650551095897·MICROWIRE DEPTHALON ELECTRODE, 12 MICROWIRE CON...
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
DEPTHALON®
FDA UDI
PMT CORPORATION·00650551096030·MICROWIRE DEPTHALON ELECTRODE, 12 MICROWIRE CON...
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 13, 2014
VASOVIEW 6 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 8, 2011
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
50 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·October 27, 2022
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·February 2, 2022
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022
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
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022