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20,344 catalysts · 4,728 grant · 3,350 8k filing · 3,076 device 510k · 2,774 approval · 2,000 device pma · 2,000 device recall
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20,344 catalysts · 4,728 grant · 3,350 8k filing · 3,076 device 510k · 2,774 approval · 2,000 device pma · 2,000 device recall
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
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions. — Reason: Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel. — Status: Ongoing
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS — Reason: Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel. — Status: Ongoing
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH, 401310RH, 401311RH, 401312RH, 401317RH, 401353RH, 401357RH, 401381RH, 401392RH, 401399RH, 401400RH, 401425RH, 401430RH, 401433RH, 401434RH, 401435RH, 401436RH, 401438RH, 401441RH, 401442RH, 401445RH, 401443RH, 401444RH, 401448RH, 401449RH, 401450RH, 401451RH, 401453RH, 401466RH, 401468RH, 401474RH, 401475RH, 401859RH, 401860RH, 401863RH, 401864RH, 401865RH, 401876RH, 401877RH, 401878RH, 401890RH, 401891RH, 401892RH, 401893RH, 401966RH, 401967RH, 401979RH, 401994RH, 401996RH, 402004RH, 402008RH, 402009RH, 402010RH, 402011RH, 402012RH — Reason: Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. — Status: Ongoing