15 results · 32ms · Sources: EU EUDAMED, 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