18 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SMARTGRAFT 200 SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304232648·
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037947·Unitek(TM) Bicuspid Band General Purpose Wide U...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011141713100·Palatal cup brush for polishing machines, ø 30 mm
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011141713000·Palatal cup brush for polishing machines, ø 30 mm
Verteloc Spinal System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215129088·
K2M General Instruments
FDA UDI
VB Spine LLC·10888857583191·Modular Trial 22x8x18mm, 7°
LIPCOLLECTOR II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUPER REVO HERCULINE SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 27, 2011
D902 LILLIPUT ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022
ULTRAXX NEPHROSTOMY BALLOON AND SET
FDA Adverse Event
Malfunction
·COOK INC·Product code LJE·August 8, 2024
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024