23 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CorMatrix Tyke
FDA 510(k)
FDA Class 2
·Cardiovascular
Simpact Tri-Fin
FDA UDI
Life Spine, Inc.·00190837062873·7mm Drill, Cannulated
ENDURANCE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295057314·FEMORAL STEM 12/14 TAPER ENDURANCE HIP STEM SIZ...
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOTRACHEAL TUBE CHANGERS
FDA 510(k)
FDA Class 2
·Anesthesiology
BASIX COMPAK INFLATION SYRINGE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·March 14, 2011
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·June 3, 2019
ACCU-CHEK MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 7, 2011
ENRHYTHM
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·June 7, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·July 24, 2019
TIBIAL INSERT FB SZ 3 RT 10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·April 13, 2023
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
FDA Enforcement
Class II
·Terminated·Value Plastics, Inc.·March 16, 2016
SYNDEO PCA SYRINGE PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE (SG)·Product code MEA·December 6, 2006
UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING (1) TUR Y SET, 2 LEAD, ST. (1) BAG SUTURE FLORAL (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV (2) TOWEL CLAMP (1) DRAPE LITHOTOMY W/LEGGIN I POUCH UF 11 0" x 63" (2) SHEET DRAPE 41 " X 58" SMS (1) COVER TABLE REINF 50" X 90" (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX (3) TOWELS ABSORBENT 15" X 20" (1) GOWN IMP. SMS EXTRA REINF. XL T/WRAP LEVEL IV (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TIME OUT BEACON NON WOVEN ST. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014