16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OEC(R) 9800, OEC(R) 9800 PLUS
FDA 510(k)
FDA Class 2
·Radiology
A Series
FDA UDI
Respironics, Inc.·00606959039629·A Series System One Heated Humidifier, US
StaXx® XD System
FDA UDI
Spine Wave, Inc.·10840642100693·Cartridge Lordotic Expandable Implant 25x9x7mm ...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089452743·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033825·Coupling Treatment Tube for 5F Flexibles (19)
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551811·IN-OVATION® mini EURO 018/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551821·IN-OVATION® mini EURO 018/5-5 CBC HK
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089466672·
TI TITAMAX IMPLANT (4.1)4.0X17
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·November 9, 2017
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
FDA 510(k)
FDA Class 1
·Dental
SURE CHECK PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X380MM X 125°
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·April 12, 2013
STAR S4 IR EXCIMER LASER
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code LZS·May 14, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·August 13, 2008
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021