9 results
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24ms
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Sources: EU EUDAMED, US FDA
MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Patterson
FDA UDI
PATTERSON DENTAL SUPPLY, INC.·D6620708718221·FILE, PULP CANAL, ENDODONTIC
Nasal Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668108550·NASAL SPECULUM ADULT
NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 17, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 13, 2012
RENAL- DISPOSABLE
FDA Adverse Event
Malfunction
·Product code FKX·October 16, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022