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13,407 catalysts · 3,431 8k filing · 2,401 grant · 2,076 approval · 1,436 device 510k · 1,072 device recall · 1,000 device adverse event
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13,407 catalysts · 3,431 8k filing · 2,401 grant · 2,076 approval · 1,436 device 510k · 1,072 device recall · 1,000 device adverse event
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
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Supplement type: Panel Track. Product code: SGS. Advisory committee: NE. Decision: APPR
Male Fertility Sperm Test for Home Use (Cassette) — Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. — Status: Ongoing
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test — Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. — Status: Ongoing
Vivoo Protein Test — Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. — Status: Ongoing
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI) — Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. — Status: Ongoing