26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971185·
TROPHON
FDA 510(k)
FDA Class 2
·Radiology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970010·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970027·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970126·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172974018·UniTip High Resolution Catheter 10F
LASER 4SPSC340
FDA 510(k)
FDA Class 2
·Physical Medicine
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EXPEDIUM SINGLE-INNER SETSCREW
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·May 9, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 19, 2014
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·May 25, 2011
AMISTEM H HA COATED LAT STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 28, 2018
VAPR3 FOOTSWITCH *EA
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HRX·October 10, 2024
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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