16 results · 29ms · Sources: EU EUDAMED, 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