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18,639 catalysts · 4,728 grant · 3,189 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
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18,639 catalysts · 4,728 grant · 3,189 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
Heartstring III Proximal Seal System. Intravascular anastomosis occluder. — Reason: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. — Status: Ongoing
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5) — Reason: Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. — Status: Ongoing
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder. — Reason: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. — Status: Ongoing
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters. — Reason: Potential for activation of an abnormal alarm pause. — Status: Ongoing
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11. — Reason: Potential for barb non-engagement. — Status: Ongoing
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/ — Reason: Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. — Status: Ongoing
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder. — Reason: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. — Status: Ongoing
Product code: GXI. Advisory committee: Neurology. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DSH. Advisory committee: Cardiovascular. Type: Traditional
Product code: LTT. Advisory committee: Microbiology. Type: Traditional
Product code: QRG. Advisory committee: Anesthesiology. Type: Traditional
Product code: GZJ. Advisory committee: Neurology. Type: Special
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DJG. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: FIE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PBH. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: HSX. Advisory committee: Orthopedic. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: TG THERAPEUTICS, INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: TG THERAPEUTICS, INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION
Supplement type: 30-Day Notice. Product code: PFN. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKM. Advisory committee: CV. Decision: OK30
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000 — Reason: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. — Status: Ongoing
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. — Reason: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard." — Status: Ongoing
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m — Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. — Status: Ongoing
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 — Reason: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. — Status: Ongoing
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202 — Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. — Status: Ongoing
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. — Reason: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard." — Status: Ongoing
Product code: OBP. Advisory committee: Neurology. Type: Traditional
Product code: JOW. Advisory committee: Cardiovascular. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Abbreviated
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION