12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RASPS FOR SCRAPING BONE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LA Repl. Cvr. (1Hr) 10-Pk
FDA UDI
SYNERON MEDICAL LTD·37290109950342·LA Repl. Cvr. (1Hr) 10-Pk, VelaShape II
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704294057·
NA
FDA UDI
KEY SURGICAL, INC.·10849771050121·Steinmann Pins, Double diamond, threaded, 5/32-...
10M - Premium - Metal Red
FDA UDI
Certified Safety Manufacturing, Inc.·00766588777450·10M - Premium - Metal Red
PANEL, GNF, MICRO-ID
FDA 510(k)
FDA Class 1
·Microbiology
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
FDA 510(k)
FDA Class 2
·Neurology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 24, 2014
RX NEEDLE KNIFE XL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·October 4, 2012
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·May 13, 2015
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018