14 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COLLAGEN WOUND DRESSING - ORAL
FDA 510(k)
FDA Unclassified
·Unknown
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004035·PowerChem Neoprene Exam Gloves, Medium
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911040403·CUBE PESSARY W/ DRAINAGE HOLES #3
BiomarC®
FDA UDI
Carbon Medical Technologies, Inc.·00858015005585·Preloaded Carbon Tissue Marker, Needle Tip Deli...
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291102113·SS Suture, 1 per sleeve
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·April 8, 2013
COBAS MIRA ISE MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 7, 2008
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·April 5, 2011
PF-VIRTEC SYSTEM CMTED LAT.6
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·August 6, 2019
Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250
FDA Recall
Terminated
·Elan Diagnostics, Inc.·Product code CHH·November 7, 2002
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
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