20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
FDA 510(k)
FDA Class 2
·Anesthesiology
Rounded Flexi Tip Adult Enema Tip
FDA UDI
Bracco Diagnostics Inc.·10815112020993·Rounded Flexi Tip
Rounded Flexi Tip Adult Enema Tip
FDA UDI
Bracco Diagnostics Inc.·10815112021167·Rounded Flexi Tip
Surgimedics®
FDA UDI
COASTAL LIFE TECHNOLOGIES, INC.·00814716020104·Smoke Evacuation Filter
Tasso+
FDA UDI
Tasso Inc.·00850038691004·
METZENBAUM PREPARATION SCISSORS INSERT
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929013010·METZENBAUM PREPARATION SCISSORS STRAIGHT DOUBLE...
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221111357·3M™ Victory Series™ First Molar Bands Kit, Lowe...
ORTHOPANTOMOGRAPH™ OP 3D
FDA UDI
PaloDEx Group Oy·06430035875177·ORTHOPANTOMOGRAPH™ OP 3D EX (PAN 3D)
Miracle Suction FULL Kit
FDA UDI
DiaDent Group International·08806383524445·Multifunctional Mirror with Suction
EYEVAN7285
FDA UDI
EYEVAN INC.·04571445021098·
ShurFit MALIF System
FDA UDI
PRECISION SPINE, INC.·00840019925228·Cup Curette 4mm Straight Up Cup
STALIF MIDLINE
FDA 510(k)
FDA Class 2
·Orthopedic
LIFE SPINE STAND-ALONE SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 30, 2019
FORTIFY VR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 30, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 8, 2013
PALMAZ GENESIS ON AMIIA
FDA Adverse Event
Injury
·CORDIS EUROPA, N.V.·Product code FGE·November 17, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
SmartPath to dStream for 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021