13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tiger Supply Inc.
FDA UDI
TIGER SUPPLY, INC.·D82360817151·VPS Impression Material Heavy Body Regular Set ...
MACROPORE IB RESORBABLE PLUG
FDA 510(k)
FDA Class 2
·Orthopedic
POWDERED PATIENT EXAMINATION GLOVES, LATEX
FDA 510(k)
FDA Class 1
·General Hospital
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LOD·October 18, 2019
5.5MM DRILL BIT W/STOP STRYKER J-LATCH/125MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HTW·April 29, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 12, 2011
LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·July 4, 2008
PINNACLE MTL INS NEUT40IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 3, 2012
ASPHERE M SPEC 12/14 40 +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 3, 2012
The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.
FDA Enforcement
Class II
·Terminated·EKOS Corporation·October 5, 2016
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018