15 results
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20ms
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Sources: EU EUDAMED, US FDA
ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Premier Excavators
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783008395·Excavator DE_OC 13(C18)
GE
FDA UDI
Conmed Corporation·10653405002635·RADIOTRANSLUCENT LEADWIRE
S52D DIGITAL VIDEO LAPAROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
FDA 510(k)
FDA Class 2
·General Hospital
X3 TRIATHLON CS INSERT #3 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014
ULTIPACE¿ LEAD, 65CM MRI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·October 28, 2025
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTL·June 14, 2011
NORIAN ROTARY MIXER
FDA Adverse Event
Malfunction
·NORIAN·Product code MQV·February 28, 2013
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·March 1, 2011
GAYMAR HEAT THERAPY PUMP
FDA Adverse Event
Malfunction
·HILLROM·Product code ILO·February 22, 2008
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 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
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018