20 results · 20ms · Sources: EU EUDAMED, US FDA

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Hi-Torque JET Guide Wire Family

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526550148·GENUMEDI PT KNEE SUP SILVER L EW V

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704508499·SCISSORS LISTER BANDAGE 5.75"

LACTOSORB* 1.5MM SYSTEM TEMPLATE

FDA UDI
BIOMET MICROFIXATION, INC·00841036095000·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694016759·MFx 125 Degree Angulated Locking Contoured Reco...

Caplugs/Evergreen

FDA UDI
CAPlugs·00810044205367·CENT TUBE 15ML UNTHREADED

Caplugs/Evergreen

FDA UDI
CAPlugs·00810044205350·CENT TUBE 15ML UNTHREADED

Caplugs/Evergreen

FDA UDI
CAPlugs·00810044206630·CENT TUBE 15 ML UNTHREAD MINI

LIFECARE ARM & LEG PAIN RELIEF SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

MENDEC SPINE

FDA 510(k)
FDA Class 2 ·Orthopedic

SENSOR ENLITE

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 5, 2014

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 3, 2013

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 10, 2015

TMC SPEEDMTP

FDA Adverse Event
Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025

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

da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

FDA Enforcement
Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

FDA Enforcement
Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

FDA Enforcement
Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015