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

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INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS

FDA 510(k)
FDA Class 3 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526189812·LEVAMED ACTIVE ANKLE SUP BLACK R VI

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001536·artVeneer life upper anteriors, BOM, BL1

SYNTHES ANTERIOR CSLP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)

FDA 510(k)
FDA Class 2 ·Microbiology

LONGY-N IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·June 4, 2025

LONGY-N IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·November 3, 2025

RESTYLANE-L INJECTABLE GEL

FDA Adverse Event
Other ·Q-MED AB·Product code LMH·March 8, 2013

REPLACEMENT TUBE

FDA Adverse Event
Malfunction ·ABBOTT NUTRITION·Product code KNT·January 26, 2011

LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code MAF·February 21, 2008

HAMILTON MEDICAL AG

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·February 13, 2024

TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWQ·September 9, 2015

LIGHT ADJUSTABLE LENS (LAL)

FDA Adverse Event
Injury ·RXSIGHT, INC.·Product code PZK·June 10, 2022

CTR34, 11X100 KII OPT ZTHR HDL 6/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·August 2, 2022

CTR34, 11X100 KII OPT ZTHR HDL 6/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·August 2, 2022

CTR34, 11X100 KII OPT ZTHR HDL 6/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·August 2, 2022

Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.

FDA Recall
Terminated ·Alpha Omega Services Inc·Product code IWJ·November 15, 2007

Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

FDA Enforcement
Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

Xhibit Telemetry Receiver, Model: 96280

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025