9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenZ HT+ 95x22 C4
FDA UDI
ARGEN CORPORATION, THE·D818122783·Dental porcelain/ceramic restoration kit
TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS
FDA 510(k)
FDA Class 2
·General Hospital
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·May 21, 2013
ASR ACETABULAR IMPLANT 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 3, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·February 5, 2008
PALMAZ SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·NEW JERSEY PLANT·Product code MAF·December 5, 1997
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025