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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Nordica PV Cryo Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Probes, Lacrimal
FDA UDI
KATENA PRODUCTS, INC.·00841668114353·LACRIMAL INTUBATION SET (BX/3)
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376364902·IdentiTi ALIF SA, Tamp, Straight, Footed
Ophthalmic Spoon
FDA UDI
KATENA PRODUCTS, INC.·00841668103418·KEENER NUCLEUS DIVIDER
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702647297·ELVAREX FORTE 3/THIGH HIGH/SLANT-OPEN TOE-ELEPH...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702778694·ELVAREX 2/KNEE HIGH/SLANT-CLOSED TOE-ELEPHANTIA...
X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
WAVi SCAN EEG System and Accessories
FDA 510(k)
FDA Class 2
·Neurology
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code DHA·November 6, 2014
AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC.·Product code OTP·July 16, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 18, 2015
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024