17 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
CliP Partial Prosthesis Titanium
FDA UDI
Heinz Kurz GmbH·EHKM10022731·Ossicular Prosthesis, partial
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964017900·The ENDO CARRY-ON Procedure Kit contains all of...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092102695·Astra®-compatible Lilac 4.5/5.0mm Esthetic Abut...
FingerClip
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616010405·FingerClip F-3212-25 SunTech
SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STARION INSTRUMENTS POWER POINT CAUTERY CLAMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEPUY ASR XL FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 13, 2013
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 18, 2011
PFC SIGMA/OV/DOME PAT 3PEG,35
FDA Adverse Event
Injury
·DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS·Product code JWH·February 20, 2008
UNKNOWN ALLOCLASSIC VARIALL HIP
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 15, 2017
BD PLASTIPAK ¿ - 3-PIECE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 14, 2023
UNKNOWN ALLOCLASSIC VARIALL STEM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·February 15, 2017
HAND PIECE FOR BATTERY POWERED DRIVER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 21, 2025
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