18 results
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28ms
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Sources: EU EUDAMED, US FDA
NARKOMAT, MODEL 2000
FDA 510(k)
FDA Class 2
·Anesthesiology
PowerPICC Provena SOLO
FDA UDI
Bard Access Systems, Inc.·00801741215704·Catheter Placement Kit
Preat
FDA UDI
Preat Corporation·00842092183878·ASC NobelActive?/Conical-compatible RP X 9mm No...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040094645·Finger spreaders 25 mm A
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810009951·LUKS FINGER PLUGGER 25MM
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040004586·Natural Elegance Syringe
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CRANIAL DRILL
FDA 510(k)
FDA Class 2
·Neurology
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·January 30, 2026
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013
ZIMMER MILLER GALANTE ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER INC·Product code HSX·February 21, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·February 19, 2008
CUSTOM TUBING
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code DWE·July 5, 2023
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022