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