15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Curing Light, Model: MaxCure 9
FDA 510(k)
FDA Class 2
·Dental
LCP
FDA UDI
Synthes GmbH·10886982157652·3.5MM LCP® METAPHYSEAL PLATE 14 HOLES
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613327419284·BONE SCREWS, CROSS-PIN, CUTTING FLUTE
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540355813·Bone Screws, Cross-Pin
SPECBOARD JR.
FDA 510(k)
FDA Class 2
·Radiology
MIDA ALGORITHM REV. B
FDA 510(k)
FDA Class 2
·Cardiovascular
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
NANOS FEMORAL NECK PROSTHESIS NONCEM 6
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS AG·Product code LZO·April 3, 2019
REF SPHER HEAD SCREW 25MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MEH·April 3, 2019
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 4, 2014
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·August 25, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
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