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17,938 catalysts · 4,728 grant · 3,605 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
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17,938 catalysts · 4,728 grant · 3,605 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
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
S. Typhi/Para Typhi A Antigen — 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
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone 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 pH 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 Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration 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
LH One Step Ovulation Test Device (Urine) — 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
Menopause Test Cassette (Urine) — 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 Vaginal pH 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
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION
Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: PFIZER. Form: SPRAY, METERED. Route: NASAL
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: SUN PHARM INDS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION
Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION
Sponsor: SOLARIS PHARMA CORP. Form: CREAM. Route: TOPICAL
Sponsor: HORIZON THERAPEUTICS IRELAND. Form: INJECTABLE. Route: INJECTION
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: BTM. Advisory committee: Anesthesiology. Type: Traditional
Product code: QEZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: DTZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: QEX. Advisory committee: Cardiovascular. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: DSB. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: PRL. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OTE. Advisory committee: RA. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: ONU. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: PHP. Advisory committee: PA. Decision: APPR
Supplement type: Real-Time Process. Product code: OZG. Advisory committee: CV. Decision: APPR
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. — Reason: Removal of affected lot of screws due to labeling error. — Status: Ongoing
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02 — Reason: For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump. — Status: Ongoing
Zimmer Air Dermatome, Model/Catalog Number: 00880100100 — Reason: The devices may have a misaligned thickness control bar. — Status: Ongoing
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. — Reason: A certain component of affected devices was not delivered within specification and contained impurities. — Status: Ongoing