21 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURFACE BEACON TRANSPONDERS
FDA 510(k)
FDA Class 2
·Radiology
7920 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136020242·7920 LG ADULT M/F MASK W/2600
DUO PAL 6, ORDER-NO.: 2154
FDA 510(k)
FDA Class 2
·Dental
PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD VACUTAINER® Z 5 ML 13X75MM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 4, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·September 17, 2014
SROM STM STD 36+ 12L 13X18
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code LPH·May 18, 2011
SYRINGE 1ML S/T W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 9, 2020
XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIQ·October 16, 2020
XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIQ·October 19, 2020
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MAF·October 7, 2020
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MAF·October 7, 2020
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MAF·October 7, 2020
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MAF·October 7, 2020
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MAF·October 7, 2020
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code LOX·October 29, 2020
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021
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
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021