15 results
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18ms
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Sources: EU EUDAMED, US FDA
HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588
FDA 510(k)
FDA Class 2
·General Hospital
POSITIONER, ADJUSTABLE SURGICAL THYROID
FDA UDI
ALIMED, INC.·00733657285437·
CATHETER, UMBILICAL ARTERY
FDA 510(k)
FDA Class 2
·General Hospital
COOLTOUCH VARIA ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GEM FLOW COUPLER DEVICE AND SYSTEM
FDA Adverse Event
Malfunction
·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·October 8, 2015
GEM FLOW COUPLER DEVICE AND SYSTEM
FDA Adverse Event
Injury
·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·October 8, 2015
GEM FLOW COUPLER DEVICE AND SYSTEM
FDA Adverse Event
Injury
·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·October 8, 2015
GEM FLOW COUPLER DEVICE AND SYSTEM
FDA Adverse Event
Injury
·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·October 8, 2015
GEM FLOW COUPLER DEVICE AND SYSTEM
FDA Adverse Event
Injury
·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·October 8, 2015
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·January 30, 2013
BIOMET ORTHOPEDICS
FDA Adverse Event
Injury
·BIOMET·Product code JDI·January 11, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL -NEUROMODULATION·Product code GZB·July 22, 2014
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators
FDA Recall
Open, Classified
·Sklar Instruments·Product code HDQ·December 3, 2024
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