20 results · 20ms · Sources: EU EUDAMED, US FDA

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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