calendar
19,907 catalysts · 4,728 grant · 3,350 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
next 91 dayslessmore
MonWedFri
19,907 catalysts · 4,728 grant · 3,350 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. — Reason: Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. — Status: Ongoing
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Product code: MBF. Advisory committee: Orthopedic. Type: Traditional
Product code: OBP. Advisory committee: Neurology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: CCL. Advisory committee: Anesthesiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: EOB. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: FET. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QDQ. Advisory committee: Radiology. Type: Special
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: PRC. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: SDA. Advisory committee: AN. Decision: APPR
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MFK. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. — Reason: Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. — Status: Ongoing
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. — Reason: Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. — Status: Ongoing
Artis Pheno. Image-Intensified Flouroscopic X-Ray System. — Reason: Limited system movements after startup . — Status: Ongoing
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. — Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. — Status: Ongoing
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. — Reason: Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. — Status: Ongoing
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. — Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. — Status: Ongoing
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. — Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. — Status: Ongoing
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. — Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. — Status: Ongoing
Product code: DQD. Advisory committee: Cardiovascular. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: BSK. Advisory committee: Anesthesiology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: MPB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JTN. Advisory committee: Microbiology. Type: Traditional