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46 catalysts · 20 approval · 18 device 510k · 5 device pma · 3 device recall
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46 catalysts · 20 approval · 18 device 510k · 5 device pma · 3 device recall
Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL
Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL
Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL
Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: CHECKPOINT THERAPEUTICS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: ALKEM LABS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAMUSCULAR
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: LABS JUVISE. Form: CAPSULE. Route: ORAL
Sponsor: THEA PHARMA. Form: GEL. Route: OPHTHALMIC
Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL
Sponsor: ANDA REPOSITORY. Form: SOLUTION. Route: ORAL
Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: CIPLA. Form: AEROSOL, METERED. Route: INHALATION
Sponsor: SANDOZ. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: POS. Advisory committee: Neurology. Type: Traditional
Product code: OMP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: EBI. Advisory committee: Dental. Type: Traditional
Product code: LBH. Advisory committee: Dental. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Special
Product code: QLY. Advisory committee: General Hospital. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: HBG. Advisory committee: Neurology. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: QUO. Advisory committee: Cardiovascular. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OMB. Advisory committee: Neurology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Supplement type: Special (Immediate Track). Product code: PQP. Advisory committee: PA. Decision: APPR
Supplement type: Real-Time Process. Product code: LNR. Advisory committee: GU. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: OTE. Advisory committee: RA. Decision: APPR
Supplement type: Real-Time Process. Product code: NCD. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC — Reason: Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration. — Status: Ongoing
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. — Reason: Emphasizing instructions for LVP duration programming located in the IFU. — Status: Ongoing
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody. — Reason: Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment. — Status: Ongoing