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14,148 catalysts · 3,230 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
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14,148 catalysts · 3,230 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: NPT. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: MIH. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MYL. Advisory committee: MI. Decision: APPR
Supplement type: Panel Track. Product code: MJO. Advisory committee: OR. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: NCD. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10775; ANESTHESIA CIRC ADULT 120-LF DYNJAA10601; ANESTHESIA CIRCUIT - LF DYNJAA10261B; ANESTHESIA CIRCUIT 120EXP-LF DYNJAA10741A; ANESTHESIA CIRCUIT ADULT-LF DYNJAA0380A DYNJAA10641 DYNJAA10706B DYNJAA10851 DYNJAA10922B DYNJAA10971A DYNJAA11030A DYNJAA11087 DYNJAA11126; ANESTHESIA CIRCUIT-LF DYNJAA0309A DYNJAA0368A DYNJAA10368A DYNJAA10392 DYNJAA10430A DYNJAA10547A DYNJAA10639A DYNJAA10656A DYNJAA10685A DYNJAA10685B; CIRC 120" EXP 1 BV HMEF 3L GSL DYNJAA10920; EXPANDABLE CIRCUIT-LF DYNJAA11095; NM ANESTHESIA TURNOVER KIT DYNJAA0433; PROV HEALTH HEPA CIRC #2-LF DYNJAA0360; SPTMPX01IA CIRCUIT ADULT-LF DYNJAA10973A; — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Convenience Kit, BREAST HERNIA DYNJ909125G — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550 — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System — Reason: Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death. — Status: Ongoing
Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230 — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Product code: QYT. Advisory committee: Microbiology. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: PAY. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S — Reason: Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted. — Status: Ongoing
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light — Reason: Due to battery component overheating while charging resulting in melting of internal components and causing smoke. — Status: Ongoing
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer — Reason: Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients. — Status: Ongoing
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only — Reason: Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. — Status: Ongoing
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LHI. Advisory committee: General Hospital. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MMK. Advisory committee: General Hospital. Type: Traditional
Product code: MPD. Advisory committee: Cardiovascular. Type: Special
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: MMK. Advisory committee: General Hospital. Type: Traditional
Product code: EBZ. Advisory committee: Dental. Type: Traditional
Supplement type: 30-Day Notice. Product code: QMG. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30