16 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CURRY MULTIMODAL NEUROIMAGING SOFTWARE
FDA 510(k)
FDA Class 2
·Neurology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092104330·Biomet 3i Certain®-compatible 4.1mm 17° Multi-U...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092131206·Biomet 3i Certain®-compatible 4.1mm 17° Multi-U...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756631648·ADULT ANESTHESIA CIRCUIT
DIRECT TIBC KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810
FDA 510(k)
FDA Class 2
·Cardiovascular
PHENOM CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·April 28, 2026
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·March 13, 2013
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 3, 2011
N'VISION
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·February 19, 2008
HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·October 12, 2021
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
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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