22 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
FDA 510(k)
FDA Class 2
·Ophthalmic
PerformaTrak
FDA UDI
Respironics, Inc.·00606959042483·Philips Procedure, PerformaTrak with Filtered E...
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925011922·HOUGH PICK 90 DEGREE TIP ANGLE .30 MM TIP LENGT...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180548·Integra® Jarit® Dressing Forceps, 7-1/4", Serra...
ArgenZ HT+ 98x14 A2B
FDA UDI
ARGEN CORPORATION, THE·D818130117·Dental porcelain/ceramic restoration kit
OsteoMed
FDA UDI
OSTEOMED LLC·00845694033688·1.6mm Inferior Orbital Rim Plate, Right
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450189603·
Tecno
FDA UDI
TECNO INSTRUMENTS (PVT) LTD·08964003293048·Graves Vu-More (Large)
Realstar Surgical
FDA UDI
REAL STAR SURGICAL INSTRUMENTS·00850071684070·Vu-More (Graves), Large
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742112893·LYNX Distal Tibial Antero Lat Locking Plate, Ti...
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
ENHANCE SPERM FREEZE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DELTAFILL18 8MM X 35CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·July 29, 2020
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 31, 2017
STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code FRC·May 24, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 30, 2014
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·June 16, 2011
BD PHASEAL PROTECTOR P50J
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·July 7, 2023
INFANT CONTINUOUS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 21, 2013
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
FDA Enforcement
Class II
·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017