22 results
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27ms
·
Sources: EU EUDAMED, US FDA
PARE ENDOSCOPIC SUTURING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MPS 3 Delivery Set w/AA w/305cm Line
FDA UDI
QUEST MEDICAL INC·00634624531024·
MPS 3 Mini Prime Delivery Set w/AA w/o Line
FDA UDI
QUEST MEDICAL INC·00634624731028·
Laminated Bite Wafers-Wax
FDA UDI
Denplus Inc·D8453003102·Laminated Bite Wafers-Wax, White, 35 units
PVA (Zn) Fix/10% Formalin 25 sets
FDA UDI
Alpha-TEC Systems, Inc.·00816085022314·PVA (Zn) Fix/10% Formalin 25 sets
MPS 3 Delivery Set w/AA w/183 Line (10C)
FDA UDI
QUEST MEDICAL INC·00634624500327·
BOTANIQ
FDA UDI
Inspecs U.S.A., L.C.·00841543148411·SUNGLASS
INJECTOR LUER LOCK N35C MULTIPACK
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·February 10, 2021
Diamondback Peripheral
FDA UDI
Cardiovascular Systems, Inc.·10852528005930·Diamondback Peripheral, Exchangeable Series, Ca...
VITROS IMMUNODIAGNOSTIC PRODUCTS SIGNAL REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code PPM·January 8, 2026
PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
FDA 510(k)
FDA Class 2
·General Hospital
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
FDA 510(k)
FDA Class 2
·Clinical Chemistry
5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·March 13, 2013
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
FDA Adverse Event
Other
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·February 3, 2011
IMPLANTIUM
FDA Adverse Event
Other
·DENTIUM CO., LTD.·Product code DZE·February 22, 2008
VERCISE GENUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·February 6, 2026
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·December 20, 2019
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016