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18,004 catalysts · 4,728 grant · 3,603 8k filing · 2,593 approval · 1,945 device 510k · 1,575 device recall · 1,351 device pma
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18,004 catalysts · 4,728 grant · 3,603 8k filing · 2,593 approval · 1,945 device 510k · 1,575 device recall · 1,351 device pma
Sponsor: TRIS PHARMA INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL
Sponsor: ABON PHARMS LLC. Form: TABLET. Route: ORAL
Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR
Sponsor: EUGIA PHARMA. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: TAKEDA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL
Sponsor: COMMAVE THERAP. Form: CAPSULE. Route: ORAL
Sponsor: ALKEM LABS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: CHARTWELL RX. Form: FOR SUSPENSION. Route: ORAL
Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION
Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION
Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR
Sponsor: HERITAGE PHARMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: TAKEDA PHARMS USA. Form: TABLET, CHEWABLE. Route: ORAL
Sponsor: RHODES PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: TRIS PHARMA INC. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL
Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS
Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL
Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL
Sponsor: NEOS THERAPS INC. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Traditional
Product code: SFU. Advisory committee: Clinical Chemistry. Type: Direct
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OKJ. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KRH. Advisory committee: Cardiovascular. Type: Abbreviated
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Special
Supplement type: 30-Day Notice. Product code: PJQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30
Supplement type: 30-Day Notice. Product code: QAN. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: SDL. Advisory committee: AN. Decision: APPR
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971. — Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data. — Status: Ongoing
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008. — Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data. — Status: Ongoing
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028 Klassic BiPolar Head, 45 mm OD, 28 mm Head; 3205.46.028 Klassic BiPolar Head, 46 mm OD, 28 mm Head; 3205.47.028 Klassic BiPolar Head, 47 mm OD, 28 mm Head; 3205.48.028 Klassic BiPolar Head, 48 mm OD, 28 mm Head; 3205.49.028 Klassic BiPolar Head, 49 mm OD, 28 mm Head; 3205.50.028 Klassic BiPolar Head, 50 mm OD, 28 mm Head; 3205.51.028 Klassic BiPolar Head, 51 mm OD, 28 mm Head; 3205.52.028 Klassic BiPolar Head, 52 mm OD, 28 mm Head; 3205.53.028 Klassic BiPolar Head, 53 mm OD, 28 mm Head; 3205.54.028 Klassic BiPolar Head, 54 mm OD, 28 mm Head; 3205.55.028 Klassic BiPolar Head, 55 mm OD, 28 mm Head; 3205.56.028 Klassic BiPolar Head, 56 mm OD, 28 mm Head; 3205.58.028 Klassic BiPolar Head, 58 mm OD, 28 mm Head; 3205.60.028 Klassic BiPolar Head, 60 mm OD, 28 mm Head — Reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. — Status: Ongoing
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys. — Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data. — Status: Ongoing
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609. — Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data. — Status: Ongoing
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair — Reason: There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop — Status: Ongoing
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927. — Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data. — Status: Ongoing