22 results
·
24ms
·
Sources: EU EUDAMED, US FDA
ACE STAPLER AND CARTRIDGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180012·Integra® Jarit® Mayo-Hegar Needle Holder, 12"
Diversatek Healthcare
FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201470·Basic Endoscopy Procedure Kit
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319703465·Ferris-Smith Tissue Forceps 7" (17.5cm), 2x3 te...
MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
FDA 510(k)
FDA Class 2
·General Hospital
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·March 4, 2024
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 10, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 4, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 10, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 8, 2021
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·January 30, 2020
MONARCH PLATFORM
FDA Adverse Event
Injury
·AURIS HEALTH, INC.·Product code EOQ·December 14, 2022
ARCHITECT C16000
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·February 12, 2024
ARCOM 28MM RNGLOC LNR HWALL 23
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 25, 2014
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 6, 2011
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code LRO·August 15, 2007
DELTAFILL18 10MM X 40CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020