17 results
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25ms
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Sources: EU EUDAMED, US FDA
REDTECH GIPC 2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Duesseldorf Type AERIAL Total Titanium
FDA UDI
Heinz Kurz GmbH·EHKM10040401·Ossicular Prosthesis, total
artegral life HD
FDA UDI
Merz Dental GmbH·D7092004040·artegral life HighDefinition posterior upper -M...
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00400401·
AOS LATERAL SUPERIOR CLAVICLE PLATE MEDIUM, RIGHT
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665006230·
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF20040400·2.0mm Cortex Screw, 1.5 Hex, Self-Tapping, 40mm
HARDYDISK CEFTRIAXONE 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ICON PREMO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·November 20, 2024
ICON PREMO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·June 26, 2025
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code OYC·January 30, 2009
ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTM·February 23, 2011
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC·Product code LWR·February 22, 2008
AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malocclusions. The AdvanSync part numbers and lot numbers affected by this recall are as follows: Part Number: 600-4000 (Kits-include 10 Right 600-4000 and 10 Left Assemblies). Lot Numbers: 070990588, 070976869, 060971515, 060971514, 04094278D Part Number: 600-4040 (5-Pack, Left Assembly). Lot Numbers: 080901333, 080902356, 070981416, 060971299, 060976084 Part Number: 600-4041 (5-Pack, Right Assembly). Lot Numbers: 080902357, 080901335, 070981417, 060971304, 060976079
FDA Recall
Terminated
·Ormco Corporation·Product code DYJ·October 2, 2009
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024
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
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016