20 results
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20ms
·
Sources: EU EUDAMED, US FDA
ASSURE LEVEL I PROD. #30171
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACUMED
FDA UDI
Acumed LLC·10806378052828·Multiple Contact Hammer
Symmetry Verity™
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031148·Verity Elevator, 3 1/2 mm Tip Width, Bayonet, 4...
Zavation
FDA UDI
Zavation LLC·00842166112452·Z-Link Lumbar Spacer 15eg 38mmx11
Zavation
FDA UDI
Zavation LLC·00842166112490·Z-Link Lumbar Spacer 15eg 38mmx19
Zavation
FDA UDI
Zavation LLC·00842166112476·Z-Link Lumbar Spacer 15eg 38mmx15
Zavation
FDA UDI
Zavation LLC·00842166112483·Z-Link Lumbar Spacer 15eg 38mmx17
Zavation
FDA UDI
Zavation LLC·00842166112469·Z-Link Lumbar Spacer 15eg 38mmx13
TUTOPATCH, TUTOMESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014
VIPER2 X-TAB POLYAXIAL DRIVER
FDA Adverse Event
Malfunction
·DEPUY RAYNHAM·Product code LXH·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 16, 2007
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997
POLARUS® 3 PROXIMAL LOCKING NAIL 150MM L
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·January 8, 2025
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025