23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517295859·CoRoent® XL-H, 8x22x60mm 20°
DJO SURGICAL
FDA UDI
DJO, LLC·00888912539838·SPECIAL, RSP 3 BARREL DRILL GUIDE
Waterlase MDX 450 Laser System
FDA UDI
Biolase, Inc.·00647529000304·An all-tissue dental laser system intended for ...
Waterlase MDX 450 Laser System
FDA UDI
Biolase, Inc.·00647529002506·An all-tissue dental laser system intended for ...
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046163·LATERAL IMPLANT, WIDE, STANDARD, 8mm X 23mm X 60mm
Waterlase MDX 450 Laser System
FDA UDI
Biolase, Inc.·00647529003282·An all-tissue dental laser system intended for ...
M3 (MICRO-MULTILEAF COLLIMATOR)
FDA 510(k)
FDA Class 2
·Radiology
FUTURA SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 12MM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HRS·June 23, 2017
SYNCHROMED EL
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 16, 2009
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
SUTURELASSO
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·June 21, 2013
IWEAR XR SUPREME (COMFILCON A)
FDA Adverse Event
Injury
·COOPERVISION MANUFACTURING LIMITED·Product code LPM·August 8, 2011
***CAT 375-544-000***STRYKER***Arthroscopic Blade***4.0mm AGGRESSIVE PLUS***Hub Style - Formula***Red/Lt Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 200860***Expiration Date: 01/2012. ***CAT 375-554-000***STRYKER***Arthroscopic Blade***5.0mm AGGRESSIVE PLUS***Hub Style - Formula***Red/Lt Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 200860***Expiration Date: 01/2012. Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Recall
Terminated
·Ascent Healthcare Solutions·Product code HRX·January 26, 2009
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·April 18, 2014
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·April 18, 2014
BIOLOX DELTA MODULAR CERAMIC FEM HD 32/0MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·June 11, 2024
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·May 29, 2018
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·May 29, 2018