9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Neuwater TM (HydrocynTM aqua)
FDA 510(k)
FDA Unclassified
·Unknown
INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
HAMILTON-C2
FDA 510(k)
FDA Class 2
·Anesthesiology
KIT RSV 30 TEST PHYSICIAN VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GQG·July 20, 2021
PLUM XLM W/DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 24, 2013
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·June 23, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
FDA Enforcement
Class II
·Terminated·Berchtold Corp.·June 15, 2016