15 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RADIUS SNARE
FDA 510(k)
FDA Class 2
·Cardiovascular
MAS PLIF
FDA UDI
Nuvasive, Inc.·00887517207449·MAS PLIF Drill, 5.0mm Disposable
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704507447·
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695021·Digital Analog NP
LEONE SPA
FDA UDI
LEONE SPA·08033707065678·INTRAORAL ELASTICS 2,5 oz 3/8" orange
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0105020·Implant Inserter, 14-16mm, Sleeved
MODEL THERMO TEK QUICKCARE
FDA 510(k)
FDA Class 2
·General Hospital
STEAM/EO RECORD CARD, MODEL CI 121
FDA 510(k)
FDA Class 2
·General Hospital
CR TIBIAL INSERT SZ4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 28, 2023
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 22, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 29, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 7, 2008
CR TIBIAL INSERT SZ4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 28, 2023
3.5MM TI ROD 80MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KWP·January 28, 2020
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024