33 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EDEN Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446885900·SPECIAL, RSP CENTRAL DRILL GUIDE, 0°, 2.4 K WIR...
HHM
FDA UDI
Oticon A/S·05707131355201·G300 SC, MINIRITE 312 2.4G C047 HHM
NA
FDA UDI
Synthes GmbH·10886982142870·2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
Lotion/Gel Warmer
FDA UDI
COMPASS HEALTH BRANDS CORP.·00853904006087·Gray 3 Bottle Warmer (120V)
Symmetry Kleinert-Kutz
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482039342·Symmetry® Elevator, Kleinert-Kutz, Sharp, & Dis...
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2017880·2.4mm Cortex Screw, T8 Stardrive, Self-Tapping,...
ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200
FDA 510(k)
FDA Class 2
·Cardiovascular
NBD CEMENT RESTRICTOR DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYMPHONY
FDA Adverse Event
Injury
·SORIN CRM·Product code NVZ·July 12, 2017
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·October 15, 2008
SCREW-IN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 2, 2013
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MRU·January 12, 2017
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MRU·January 18, 2017
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 14, 2023
GORE DUALMESH PLUS BIOMATERIAL
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FTL·February 26, 2019
IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MRU·January 11, 2018
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·May 31, 2022