18 results · 28ms · Sources: EU EUDAMED, US FDA

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POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

Performance Health

FDA UDI
Performance Health Supply, LLC·10885914087203·SEIRIN J-TYPE 0.23X50MM Acupuncture Needle 100/pk

Bur PM2-150 80K diam EC Ø6.0 St

FDA UDI
Bien-Air Surgery SA·17630055512670·

Oticon

FDA UDI
Oticon A/S·05707131164049·ACTO, BTE 13 TC

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTL.·Product code MNI·October 14, 2011

MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS

FDA 510(k)
FDA Class 2 ·Anesthesiology

UNIQUE AMBULATORY EEG

FDA 510(k)
FDA Class 2 ·Neurology

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

SYRINGE 0.5ML 31G 6MM S/C U-100 RELION

FDA Adverse Event
Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·August 13, 2024

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 24, 2015

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code ITI·May 8, 2013

ON-Q PAINBUSTER SOAKER

FDA Adverse Event
Injury ·I-FLOW CORPORATION·Product code MEB·May 18, 2011

EAGLE EYE PLATINUM SHORT TIP

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

Alinity m System, Part No. 08N53-002

FDA Enforcement
Class II ·Terminated·Abbott Molecular, Inc.·January 12, 2022

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024