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18,273 catalysts · 4,728 grant · 3,138 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
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18,273 catalysts · 4,728 grant · 3,138 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
Model Number S722, ALTRUA 2 DR EL Pacemaker — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
ACCOLADE DR SL MRI (Model L311) — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
Product code: LTT. Advisory committee: Microbiology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: QSM. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: SFN. Advisory committee: Neurology. Type: Direct
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: NDC. Advisory committee: Anesthesiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Sponsor: RHYTHM. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NCD. Advisory committee: MI. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MIH. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: OTL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
i-STAT EG6+ cartridge. List Number: 03P77-25. — Reason: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2. — Status: Ongoing
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile — Reason: Labeling includes shelf life that has not been validated. — Status: Ongoing
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile — Reason: Labeling includes shelf life that has not been validated. — Status: Ongoing
i-STAT CG4+ cartridge (white). List Number: 03P85-25. — Reason: Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2. — Status: Ongoing
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q — Reason: The kits contain certain lots of cannula products where the catheter may not retain its shape. — Status: Ongoing
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile — Reason: Labeling includes shelf life that has not been validated. — Status: Ongoing
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300 — Reason: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2. — Status: Ongoing
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile — Reason: Labeling includes shelf life that has not been validated. — Status: Ongoing
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile — Reason: Labeling includes shelf life that has not been validated. — Status: Ongoing
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively). — Reason: Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation. — Status: Ongoing
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile — Reason: Labeling includes shelf life that has not been validated. — Status: Ongoing
i-STAT EG7+ cartridge. List Number: 03P76-25. — Reason: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2. — Status: Ongoing
Product code: LON. Advisory committee: Microbiology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: FCG. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Special