18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTRA
FDA 510(k)
FDA Class 2
·Radiology
ProCopper
FDA UDI
SILMET LTD·07290012207747·Dental Amalgam Alloy
Spherodon - M
FDA UDI
SILMET LTD·07290012207310·Dental Amalgam Capsules
Spherodon M Econom
FDA UDI
SILMET LTD·07290016787771·Dental Amalgam Capsules
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450193532·
NA
FDA UDI
STRYKER CORPORATION·07613327096576·Elite Angled Attachment
BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
SI-FIX SACROILIAC JOINT FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 21, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 16, 2025
ASR ACETABULAR IMPLANT 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code LFL·June 3, 2011
ASANTE SNAP INSULIN PUMP SYSTEM
FDA Adverse Event
Injury
·ASANTE SOLUTIONS INC.·Product code LZG·August 11, 2014
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023