21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAPRI Corpectomy Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578440·CoRoent Ant TLIF Ti, 11x11x32mm 0°
Redi Splint
FDA UDI
FARETEC, INC.·B54112113200·Redi Universal Splint, Small, Black, Folded. Mo...
NA
FDA UDI
Medos International Sàrl·20886705001627·GUIDEWIRES WITH ROUND TIPS 0.16 x 35.6cm (.062 ...
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK113201·DD tempMED are pre-colored dental milling blank...
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003355·Luna Opal R Mini .018 LU5 (-22°T 0°A)
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707185435·AccuFit™ Molar Band UR7 - 32
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551135982·HALO, 1203-5 VEST X-LARGE, COOLMAX LINER, 1211-...
ODYSSEY LX, MODEL 211320
FDA 510(k)
FDA Class 2
·Radiology
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221048998·Unitek(TM) Permachrome Standard Stainless Steel...
GLOBALCARDIO
FDA 510(k)
FDA Class 2
·Cardiovascular
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021
ENSITE CLASSIC SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DQK·February 9, 2010
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code INM·October 29, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 15, 2011
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 8, 2013
O-ARM O2 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·SANMINA -SCI SYSTEMS·Product code OWB·December 16, 2021
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025