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