87 results · 25ms · Sources: EU EUDAMED, 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