119 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014
FDA Enforcement
Class I
·Ongoing·ICU Medical, Inc.·October 29, 2025
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
FDA Enforcement
Class I
·Terminated·Avid Medical, Inc.·June 16, 2021
MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
FDA Enforcement
Class I
·Terminated·Avid Medical, Inc.·June 16, 2021
HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation
FDA Enforcement
Class I
·Terminated·Heartsine Technologies, Limited·November 7, 2012
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·April 15, 2026
Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.
FDA Enforcement
Class I
·Terminated·Enhancement Medical, LLC·August 20, 2014
Clean Catch Urine Kit NS 178489, AHMU58A
FDA Enforcement
Class I
·Ongoing·American Contract Systems, Inc.·July 13, 2022
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
FDA Enforcement
Class I
·Ongoing·American Contract Systems, Inc.·July 13, 2022
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·May 28, 2025
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
FDA Enforcement
Class I
·Terminated·Physio-Control, Inc.·March 15, 2017
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·September 14, 2022
The Tri-Flo Subglottic Suction System
FDA Enforcement
Class I
·Terminated·Vyaire Medical·August 29, 2018
STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014