calendar
13,283 catalysts · 3,603 8k filing · 2,377 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 930 device pma
next 91 dayslessmore
MonWedFri
13,283 catalysts · 3,603 8k filing · 2,377 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 930 device pma
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main, REF: 1155-00, BD Pyxis CII Safe ES, REF: 1116-00 — Reason: Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs. — Status: Ongoing
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG — Reason: Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS. — Status: Ongoing
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
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Supplement type: Panel Track. Product code: SGS. Advisory committee: NE. Decision: APPR