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Hobbs Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
73
510(k) Clearances
21
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0474-2025Class IIPosi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718October 4, 2024
Z-0469-2025Class IIPosi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702October 4, 2024
Z-0476-2025Class IIPosi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723October 4, 2024
Z-0471-2025Class IIPosi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716October 4, 2024
Z-0468-2025Class IIPosi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720October 4, 2024
Z-0470-2025Class IIPosi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706October 4, 2024
Z-0475-2025Class IIPosi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722October 4, 2024
Z-0473-2025Class IIPosi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704October 4, 2024
Z-0472-2025Class IIPosi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721October 4, 2024
Z-0069-2023Class IIHobbs Medical Polypectomy Snare Catalog Number: 4565-OLYJuly 29, 2022
Z-0049-2023Class IIFreeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501July 29, 2022
Z-0034-2023Class IIHobbs Medical Grasping Forceps Catalog Number:5004July 29, 2022
Z-0042-2023Class IIHobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028July 29, 2022
Z-0017-2023Class IIHobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620July 29, 2022
Z-0039-2023Class IIHobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023July 29, 2022
Z-0028-2023Class IIHobbs Helical Retrieval Basket Catalog Number: 4814July 29, 2022
Z-0068-2023Class IIHobbs Medical Polypectomy Snare Catalog Number: 4563-OLYJuly 29, 2022
Z-0015-2023Class IIHobbs Medical Polypectomy Snare Catalog Number: 4563July 29, 2022
Z-0050-2023Class IIFreeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503July 29, 2022
Z-0013-2023Class IIHobbs Medical Cytology Brush Catalog Number: 4204July 29, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K241874Aspiration Catheter (2189)September 24, 2024
K182927Pulmonary Cytology BrushFebruary 7, 2020
K093079TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-UAugust 2, 2010
K030765HOBBS MISTIFIER SPRAY CATHETERJune 9, 2003
K933354HOBBS MEDICAL CLEANING BRUSHOctober 28, 1993
K922396FUJINON FORCEPS -- MODIFICATIONDecember 10, 1992
K921026PRESSURE GAUGEApril 24, 1992
K914358ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIPNovember 19, 1991
K893729HOBBS MEDICAL MICROBIOLOGY BRUSHAugust 28, 1989
K872509LINDEN STONE EXTRACTION BALLOONSeptember 22, 1987
K860593ET/RT PAPILLOTOMEJuly 22, 1986
K860582TBI NEEDLEMarch 4, 1986
K844550HOBBS MEDICAL/JAYCO ASPIRATION CATHETERJanuary 3, 1985
K844074HOBBS MEDICAL POLYPECTOMY SNAREJanuary 3, 1985
K834413DILATION BALLOON CATHETERMay 22, 1984
K834401URETERAL DOUBLE PIGTAIL STENTMarch 22, 1984
K834351BILIARY INDWELLING STENTMarch 22, 1984
K834414ERCP CANNULAFebruary 4, 1984
K834402GASTROINTESTINAL SHEATH BRUSHFebruary 4, 1984
K833124HOBBS MEDICAL RETRIEVAL BASKETNovember 29, 1983