Rocket Medical Plc

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
19
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0952-2026Class IIBrand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog NumbeNovember 7, 2025
Z-0955-2026Class IIBrand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog NumbeNovember 7, 2025
Z-0951-2026Class IIBrand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog NuNovember 7, 2025
Z-0950-2026Class IIBrand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog NumbeNovember 7, 2025
Z-0953-2026Class IIBrand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog NuNovember 7, 2025
Z-0954-2026Class IIBrand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog NumbeNovember 7, 2025
Z-0512-2020Class IIRocket KCH Fetal Bladder Drainage Catheter Model: R57405August 1, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K210509Rocket Platinum Cured CathterSeptember 9, 2021
K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitAugust 17, 2017
K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitNovember 14, 2016
K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetMarch 29, 2016
K123033ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, RFebruary 1, 2013
K052365CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGEOctober 17, 2005
K042264GUIDEWIRESNovember 24, 2004
K040189ENDOMETRIAL SAMPLING SYRINGEOctober 4, 2004
K032015EMBRYON ULTRASOUND NEEDLE GUIDEAugust 8, 2003
K000205EMBRYON SINGLE AND DOUBLE LUMEN NEEDLESApril 19, 2000
K000340HYSTALOG HSG CATHETERApril 19, 2000
K994344NEUROTHERM RF CANNULAMarch 21, 2000
K000656EMBRYON GIFT TRANSFER CATHETERS/SETSMarch 9, 2000
K000394CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNITFebruary 29, 2000
K994327EMBRYON TRANSFER CATHETERS/SETSFebruary 28, 2000
K980061EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FMarch 2, 1998
K972856ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLSFebruary 11, 1998
K972867CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNITOctober 24, 1997
K961287ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEMJuly 26, 1996