19 results · 21ms · Sources: EU EUDAMED, US FDA

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WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE

FDA 510(k)
FDA Class 2 ·Neurology

Mask

FDA UDI
WESTMED, INC.·00709078014321·Mask Adult Tracheostomy

Procure

FDA UDI
Twin Med, LLC·10840330700310·Mask Adult Tracheostomy

CUSTOMED

FDA UDI
CUSTOMED INC·M20890022191·SURGICAL MASK, SOFT, WHITE, WITH TIES, 120MM HG

MySign® S

FDA UDI
Honeywell Healthcare Solutions GmbH·04036616010092·MySign® S incl. F-3211-12 MySign® FDA

BetaForce

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730022257·Beta3 Euro Lower 18x18 10 archwires per pack

Battalion

FDA UDI
ALPHATEC SPINE, INC.·00840967188782·Battalion, LLIF Trial, 0°, 22 mm Wide, 19 mm X ...

RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 21, 2022

S4 IMPLANTS

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code KWP·August 29, 2008

ARCHITECT I2000SR ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·August 5, 2013

ETRIO

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·March 13, 2013

ENDURON 10D 52OD X 28ID

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 18, 2011

CANAL REAMER 13.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HTO·February 20, 2008

BD PLASTIPAK 20ML SYRINGE LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 9, 2020

Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

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 Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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