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20,799 catalysts · 4,728 grant · 3,374 device 510k · 3,328 8k filing · 2,856 approval · 2,000 device pma · 2,000 device recall
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20,799 catalysts · 4,728 grant · 3,374 device 510k · 3,328 8k filing · 2,856 approval · 2,000 device pma · 2,000 device recall
S4-1 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
c5-1 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
V6-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
C9-4 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
L12-5 50 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
V9-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
XL14-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
X8-2t Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
C9-3io Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
L11-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
OMNI III TEE Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Orascoptic Superior Visualization Custom loupes with Dragonfly frames — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing
D2TCD Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
C5-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
L15-7IO TRANSDUCER Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
X7-2t Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing
L17-5 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
C10-3v Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver) — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing
C9-5ec Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
S8-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
S12-4 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
S7-2t Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
X3-1 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Product code: QDQ. Advisory committee: Radiology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: MQH. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QPL. Advisory committee: Neurology. Type: Traditional
Product code: ERL. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: MGZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: GZF. Advisory committee: Neurology. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: FZP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ONF. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PSZ. Advisory committee: Microbiology. Type: Traditional
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: LJE. Advisory committee: Unknown. Type: Traditional
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: PRL. Advisory committee: CV. Decision: APPR