16 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Claritas iPET
FDA 510(k)
FDA Class 2
·Radiology
MaXcess
FDA UDI
Nuvasive, Inc.·00887517190727·MaXcess Access Blade, 140mm Center
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514858·
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221049070·Unitek(TM) Permachrome Resilient Stainless Stee...
Photodynamic Bone Stabilization System
FDA UDI
ILLUMINOSS MEDICAL, INC.·M986US22131400·22/13mmx140mm Photodynamic Bone Stabilization L...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197312660·Cottle Septum Knife
with r...
VARI-LASE WIREFIBER LASER FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
GENDRON, INC.·00842307100034·STRETCHER,CHR FRM,ENAM LTR, UTILITY SHELF
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021
NA
FDA UDI
GENDRON, INC.·00842307102281·STRETCHER,CHR FRM,ENAM LTR INCLUDES: ...
ENDOVIVE? JEJUNAL FEEDING TUBE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·October 30, 2014
HALO 360 ABLATION CATHETER
FDA Adverse Event
Malfunction
·BARRX MEDICAL, INC.·Product code GEI·August 11, 2011
SELUTE PICOTIP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023