13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERMLASTIC 3
FDA 510(k)
FDA Class 2
·Dental
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159026436·DeBakey Ductus Clamp
Mariner MIS
FDA UDI
Seaspine Orthopedics Corporation·10889981171315·MIS Tap Tri-Flat, Dia 6.50mm
LINK Instruments - Drills, reamers and saw blades
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575156122·Bone trephine - Endo Model Knee System
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BETEL POWDER FREE LATEX EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
NA
FDA UDI
Zimmer, Inc.·00889024066731·
LOCK REMOVAL APPLIERS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTD·February 28, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 12, 2014
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·February 14, 2008
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018