17 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PERMLASTIC 3
FDA 510(k)
FDA Class 2
·Dental
ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD
FDA 510(k)
FDA Class 2
·Dental
NV MICROCATHETER
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 9, 2020
SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG
FDA Adverse Event
Malfunction
·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·October 8, 2024
VNGD CR INTLK FEMORAL 55MM RT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 13, 2018
BIOMET CC I-BEAM TRAY 63MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
VNGD CR TIB BRG 12X63/67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
SERIES A PAT STD 28 3 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
IEXP DDV TI SLOTTED CONN STRT
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code NKB·May 6, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 16, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 12, 2011
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
FDA Enforcement
Class I
·Terminated·Stryker Spine·August 28, 2013
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·April 28, 2022
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015