16 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electronic Blood Pressure Monitor, model: HTD6602US
FDA 510(k)
FDA Class 2
·Cardiovascular
XLIF
FDA UDI
Nuvasive, Inc.·00887517191670·XLIF Blade, 170mm Lung Retractor Narrow
PERMATAPE
FDA UDI
Medos International Sàrl·10886705027903·PERMATAPE SUTURE White/Blue Braided Flat Suture...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114018·HYDRO-DISSECT FLAT J 25GA (PK/10)
VARIAX
FDA UDI
Stryker GmbH·04546540541000·Hand Screwdriver Handle, 1.7,2.3
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197312950·Hildyard Post-Nasal Biopsy Forceps
3.5mm ...
VARI-PASS VARIABLE LENGTH ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NITRILE POWDER-FREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 12, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 12, 2013
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
XP-XP Tibial Tray - Interlok 73 mm Item # 195756
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018