11 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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JET VENTILATOR/JETTING DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122925·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 150mm
BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
FDA 510(k)
FDA Class 1
·General Hospital
AUROPAL 60
FDA 510(k)
FDA Class 2
·Dental
SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·July 31, 2019
INRATION PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO INC·Product code GJS·May 28, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·January 11, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·December 8, 2010
UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code KYF·July 14, 2022
PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 26, 2019
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022