87 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ROCKWOOD CLAVICLE PINS
FDA 510(k)
FDA Class 2
·Orthopedic
Stainless Steel Tibial Nailing System
FDA UDI
ORTHOFIX SRL·18032568867688·CALIBRATED DRILL BIT D. 4.0 MM L. 180 MM
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828144032·GEN4 INTERACTIVE
Stainless Steel Tibial Nailing System
FDA UDI
ORTHOFIX SRL·18032937169627·CALIBRATED DRILL BIT D.4 MM L.180 MM TIN COATED...
EARGO
FDA UDI
Eargo, Inc.·00850010429151·EARGO NEO HiFi, Replacement Hearing Device, Left
JUP, P1010 TO S1011 & S1012, DUMMY PLUGS, Y CABLE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828182683·JUP, P1010 TO S1011 & S1012, DUMMY PLUGS, Y CABLE
OsteoMed
FDA UDI
OSTEOMED LLC·00845694041263·2.0mm, 9 Hole Curved Plate with Screws, Sterile
MILAGRO ADV TAP, 7-8MM
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code LXH·September 20, 2021
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·August 9, 2016
METHADONE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GRAMS SILK NONABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 2, 2011
M2A 38MMX58MM CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 9, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
M2A 38MM NON-FLARED ONE-PIECE CUP 38X56MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 25, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2014
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·July 25, 2016
C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·November 9, 2022