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19,263 catalysts · 4,728 grant · 3,316 8k filing · 2,679 approval · 2,475 device 510k · 2,000 device recall · 1,737 device pma
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19,263 catalysts · 4,728 grant · 3,316 8k filing · 2,679 approval · 2,475 device 510k · 2,000 device recall · 1,737 device pma
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LTI. Advisory committee: GU. Decision: APPR
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 — Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. — Status: Ongoing
Plum Duo Infusion System, List Number: 400020401 — Reason: ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. — Status: Ongoing
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3), — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
Blood/MacConkey Biplate 100/PK, Product Number R02049 — Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. — Status: Ongoing
Strep Selective II Agar, Product Number R01859 — Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. — Status: Ongoing
BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2) — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants. — Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. — Status: Ongoing
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
Blood/EMB, Levine 100/PK, Product Number R02041 — Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. — Status: Ongoing
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants. — Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. — Status: Ongoing
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants. — Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. — Status: Ongoing
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JFB. Advisory committee: Physical Medicine. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Special
Product code: HTN. Advisory committee: Orthopedic. Type: Traditional
Product code: EMA. Advisory committee: Dental. Type: Traditional
Product code: IYO. Advisory committee: Radiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: BSZ. Advisory committee: Anesthesiology. Type: Traditional
Product code: NPM. Advisory committee: Dental. Type: Special
Product code: EMA. Advisory committee: Dental. Type: Traditional
Product code: ITX. Advisory committee: Radiology. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Abbreviated
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HIS. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: NLH. Advisory committee: Cardiovascular. Type: Traditional
Product code: OZE. Advisory committee: Microbiology. Type: Traditional
Product code: QYX. Advisory committee: Cardiovascular. Type: Traditional
Product code: GAG. Advisory committee: General Hospital. Type: Traditional
Product code: HBW. Advisory committee: Neurology. Type: Traditional
Product code: LYA. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: POS. Advisory committee: Neurology. Type: Traditional
Advisory committee: Unknown. Type: Traditional
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: JCW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: PZK. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZY. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B; 6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T; 7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H. — Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. — Status: Ongoing