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18,160 catalysts · 4,728 grant · 3,086 8k filing · 2,634 approval · 2,175 device 510k · 1,759 device recall · 1,520 device pma
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18,160 catalysts · 4,728 grant · 3,086 8k filing · 2,634 approval · 2,175 device 510k · 1,759 device recall · 1,520 device pma
Supplement type: Normal 180 Day Track No User Fee. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: PJY. Advisory committee: OR. Decision: APPR
Product code: FLE. Advisory committee: General Hospital. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JDQ. Advisory committee: Orthopedic. Type: Traditional
Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional
Product code: FMZ. Advisory committee: General Hospital. Type: Traditional
Product code: NLQ. Advisory committee: Unknown. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PMN. Advisory committee: Microbiology. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Dual Track
Product code: NPL. Advisory committee: Dental. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Product code: SFL. Advisory committee: MG. Decision: APPR
Product code: QNH. Advisory committee: PA. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: EZW. Advisory committee: GU. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: PNJ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: PNJ. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR
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