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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
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
Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341; — Reason: BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. — Status: Ongoing
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. — Reason: Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users. — Status: Ongoing
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers. — Reason: Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. — Status: Ongoing
Sponsor: YILING. Form: CAPSULE. Route: ORAL
Sponsor: YILING. Form: CAPSULE. Route: ORAL
Sponsor: UCB INC. Form: SOLUTION. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: NOVAST LABS. Form: TABLET. Route: ORAL
Sponsor: NOVAST LABS. Form: TABLET. Route: ORAL
Sponsor: MERCK SHARP AND DOHME LLC
Sponsor: TAIHO ONCOLOGY. Form: TABLET. Route: ORAL
Sponsor: ASPIRO. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ASPIRO. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: TORRENT. Form: TABLET. Route: ORAL
Sponsor: TORRENT. Form: TABLET. Route: ORAL
Sponsor: NANJING KING FRIEND. Form: SOLUTION. Route: SUBCUTANEOUS
Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing