24 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
FDA 510(k)
FDA Class 2
·Cardiovascular
TruForm
FDA UDI
Rmo, Inc.·00885797099662·MAX MOLAR BDS PEDO ASST 100
Gensini™
FDA UDI
MEDTRONIC, INC.·00763000199197·WVN CATH 001346 10PK 8F 100CM GENSINI
Gensini™
FDA UDI
MEDTRONIC, INC.·00613994964373·WVN CATH 001346 10PK 8F 100CM GENSINI
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001346·artVeneer life upper anteriors, IS, C2
TensCare
FDA UDI
TENSCARE LIMITED·05033435136490·The Nouri Digital Electric Breast Pump is a pow...
Equinoxe
FDA UDI
Exactech, Inc.·10885862623850·Humeral Liner Trial, 36mm +0 Left
Phonak Brand
FDA UDI
Sonova AG·07613389403138·myPhonak 4.0 app
Diagon
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030MO0013460·"Off-Set, Bi-Convex, 10mm x 39mm x 17mm, Obliq...
EZ CONNECT
FDA 510(k)
FDA Class 2
·Dental
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 9, 2025
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 16, 2025
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 16, 2025
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·March 6, 2013
ORTHOVISC
FDA Adverse Event
Other
·ANIKA THERAPEUTICS, INC.·Product code MOZ·February 18, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE SJ·Product code JPA·February 19, 2008
T:slim Insulin Delivery System Insulin Infusion Pump
FDA Enforcement
Class I
·Terminated·Tandem Diabetes Care Inc·February 19, 2014
Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code IWJ·November 15, 2007
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025