15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Synthes GmbH·10886982145208·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
ARCHITECT C4000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES (IRVING IA/CC)·Product code JJE·August 10, 2020
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112557·BARRON VACUUM TREPHINE 9.0MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112977·CORNEAL TREPHINE BLADE9.0MM
PRESSURE WIRE SENSOR, MODEL 12003/12303
FDA 510(k)
FDA Class 2
·Cardiovascular
WIENER LAB. BILIRRUBINA TOTAL AA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 27, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
SM, LT ULNA COMPONENT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDC·July 2, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·May 28, 2023
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021