27 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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B. BRAUN NERVE BLOCK CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
Hegar 8pc Dilator Set
FDA UDI
MEDGYN PRODUCTS, INC.·M803030830·Hegar 8pc Dilator Set 3-4mm - 17-18mm
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
FDA UDI
TENON MEDICAL, INC.·B74240308300·10mm Insertion Screw
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20308301·BioStarter wires Straight-Arch-F. max. .012"
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023888·BAYONETTED PUSH SCRAPER CURETTE
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0380300·Handle, Threaded In Line, Plastic M8
ENT ENDOSCOPES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 15, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 5, 2025
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 26, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2017
BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 25, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 4, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 6, 2017
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·April 2, 2013
FIRST PICC KIT W/ INTROSYTE-N INTRODUCER
FDA Adverse Event
Malfunction
·ARGON MEDICAL DEVICES INC.·Product code LJS·March 22, 2011
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·April 17, 2008