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

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Alma LipoFlow System

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

NA

FDA UDI
KEY SURGICAL, INC.·10849771049460·K-Wires, Single diamond, round end, .045-inch (...

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704293142·

K-Wire w. lanzet/round end 1.14mm/229mm, 6 pcs./unit

FDA UDI
mahe medical gmbh·EMAHKM712420·K-Wire w. lanzet/round end 1.14mm...

mahe medical GmbH

FDA UDI
mahe medical gmbh·04050659484610·K-Wire w. lanzet/round end _x000D_...

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·November 23, 2022

Ambler Value Line

FDA UDI
AMBLER SURGICAL CORP.·00190660214173·Crile retractor, 4 1/4'', #2, double-ended, 1/4...

GENESIS DM MODEL: 6053000A1

FDA 510(k)
FDA Class 2 ·Cardiovascular

DBEST ONE STEP OCCULT BLOOD TEST KITS

FDA 510(k)
FDA Class 2 ·Hematology

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·April 4, 2022

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·February 22, 2022

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·February 2, 2022

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·May 11, 2022

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LGD·August 14, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2013

COULTER LH750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011

HEARTSTART MRX-EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 19, 2014

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·Product code ITX·May 25, 2021