78 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PACK-LF, Pack Number DYNJ0046667A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58344; 5. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJS3016.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 6, 2026
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
FDA Enforcement
Class II
·Ongoing·EHOB, Inc.·June 30, 2021
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·November 27, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·November 27, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·November 27, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·November 27, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·November 27, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·November 27, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·November 27, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·November 27, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·November 27, 2024
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·March 9, 2022
Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·October 19, 2022
Hobbs Posi-Stop Injection Needle Catalog Number: 4722
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·October 19, 2022
Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·October 19, 2022
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·October 19, 2022
Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·October 19, 2022
Hobbs Helical Retrieval Basket Catalog Number: 4814
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·October 19, 2022
Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·October 19, 2022