34 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LessRay
FDA UDI
Nuvasive, Inc.·00887517756749·LessRay Collar, 12" C-Arm
EdgePRO™
FDA UDI
US ENDODONTICS, LLC·00818365026661·EdgePRO™ Tips Tip 1; 17mm (30 pack)
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193115757·HA PEEK EVOS Straight, ,15mmx10mmx 30mm , FLAT ...
LEONE SPA
FDA UDI
LEONE SPA·08033707022749·CALIBRA BANDS 2ND MOLAR n.SUL 15
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC
Sapphire NC ULTRA Coronary Dilatation Catheter
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955982293·
SHASER V-MINI HAIR REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATAC PAK PHOSPHORUS REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 23, 2026
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 12, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 31, 2011
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 16, 2013
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 13, 2024
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 13, 2025
MPACT ACETABULAR SYSTEM IMPLANTS
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LPH·November 5, 2025
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 18, 2025
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
FDA Recall
Open, Classified
·Stryker Corporation·Product code GEI·September 11, 2023
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
FDA Recall
Open, Classified
·Stryker Corporation·Product code GEI·September 11, 2023
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 27, 2025