20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROMANIPULATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00531421·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113943·B-H IRRIGATING CAN 19GA FLAT ANGLED 8MM
TRIFECTA
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730015327·TRIFECTA NiTiTherm Lower 16x22 10 archwires per...
NOBELREPLACE CC PMC RP 4.3X10MM
FDA Adverse Event
Injury
·NOBEL BIOCARE USA INC·Product code DZE·June 15, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
AUDIO TECHNOLOGIES S:R.1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·December 17, 2024
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·February 28, 2011
GREENLIGHT HPS BPH FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·August 12, 2014
BD PHASEAL PROTECTOR P50J
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 17, 2020
OXF TWIN-PEG CMNTD FEM MD PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·July 16, 2021
OXF ANAT BRG RT MD SIZE 5 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·July 16, 2021
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025