16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM
FDA 510(k)
FDA Unclassified
·Unknown
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450203880·
MODIFICATION TO EBI SPINELINK SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COAXIAL DILATOR SET
FDA 510(k)
FDA Class 2
·Cardiovascular
0009613348-2026-001737
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code DZE·February 2, 2026
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 21, 2022
4F M-I STIFFEN 40CM NT-SS (610366)
FDA Adverse Event
Malfunction
·GALT MEDICAL CORP.·Product code DQX·January 10, 2012
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code OUT·March 13, 2013
PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 25, 2011
LOW PROFILE EXTENSION
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code MHY·February 19, 2008
HLM TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 2016
Custom anesthesia kits labeled as follows: (1) DeRoyal (R) Adult Exp Anesthesia Circuit, REF 86-001737, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Number 25660996 (2) DeRoyal (R) Adult Anesthesia Circuit, REF 86-001781, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Numbers: 25574115, 25624514, 25661260, 25702578, 25766272, 25835901, 25835910, 25873406, 25906061, 25960681 (3) DeRoyal (R) Latex Safe Anesthesia Kit, REF 86-001641, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Numbers: 25573171, 25765667, 25834853, 25834861 (4) DeRoyal (R) Custom Anesthesia Kit, REF 86-001619, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Number 25573155 (5) DeRoyal (R) Anesthesia Kit, REF 86-001669, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Numbers: 25313484, 25702324, 25977977 Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code OGD·August 23, 2011
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024