23 results · 24ms · Sources: EU EUDAMED, US FDA

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QUATERA 700

FDA 510(k)
FDA Class 2 ·Ophthalmic

QUATERA 700 BIMANUAL I/A HANDPIECE SET

FDA Adverse Event
Injury ·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777433·LUMBAMED PLUS FLEX PAD WM SILVER I

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704514254·

Sklar®

FDA UDI
SKLAR CORPORATION·10649111301339·TC BABY WEBSTER NH SERR 4 1/4"

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450666456·

Signature BiPolar Head

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215017316·

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001

FDA 510(k)
FDA Class 2 ·Cardiovascular

IMAGEN3D

FDA 510(k)
FDA Class 2 ·Radiology

FLAT TITANIUM PECTUS BAR 10.5

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

FLAT TITANIUM PECTUS BAR 12

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 15, 2011

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900

FDA Enforcement
Class II ·Ongoing·North American Rescue LLC.·October 8, 2025

FLAT TITANIUM PECTUS BAR 11IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

FLAT TITANIUM PECTUS BAR 13IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

FLAT TITANIUM PECTUS BAR 13IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

FLAT TITANIUM PECTUS BAR 11IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

FLAT TITANIUM PECTUS BAR 11IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025