22 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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