13 results
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18ms
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Sources: EU EUDAMED, US FDA
Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517629296·CoRoent Ant TLIF Ti, 11x13x32mm 15°
CD-Chex Plus
FDA UDI
STRECK, INC.·10844509000089·A positive procedural control for monitoring im...
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116020508·Dornier Medilas H 400 Micron Single Use Laser F...
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 26, 2021
EVOLUTION MP ADAPTIVE CS INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
POINT 4 FLOWABLE 2
FDA 510(k)
FDA Class 2
·Dental
ALLTHREAD PEEK ANCHOR
FDA Adverse Event
Injury
·BIOMET SPORTS MEDICINE·Product code HWC·October 29, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
ALIGN TO URETHRAL SUPPORT SYSTEM-HOOK
FDA Adverse Event
Injury
·BARD SHANNON LTD·Product code FTL·July 2, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 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.·May 3, 2017
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026