16 results · 22ms · Sources: EU EUDAMED, US FDA

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IGG ANTI-ATHEROX TEST KIT

FDA 510(k)
FDA Class 2 ·Immunology

Paltop

FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108692426·1mm Conical Non-Engage Ti Base Abutment

Genius Total Knee System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215023065·

Hexalobe Driver Q Tip T20

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215061715·

C02 LASER MULTIPULSE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

FIRST SPEP

FDA 510(k)
FDA Class 2 ·Dental

ATTUNE PS RP INSRT SZ 6 20MM

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code NJL·March 20, 2026

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

APHIS PLATEAU RADIAL T1

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code JWJ·May 19, 2017

NON AC-POWERED PATIENT LIFT

FDA Adverse Event
Injury ·INVACARE SUZHOU·Product code FSA·April 22, 2013

STAIR PRO - MODEL 6252

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPP·April 19, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

ATTUNE FEM POR CR RT SZ 4

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code MBH·July 10, 2024

ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERIL

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code KTT·August 8, 2023

PFNA-II BLADE L90 TAN

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HSB·January 4, 2023

Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

FDA Enforcement
Class I ·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025