20 results
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19ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70715051·Starter-assortment 2D Lingual 3. Gen. mixed hook
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481113338·LOCATOR R-Tx Abutment for Ankylos Connection Im...
LOCATOR R-Tx, Dentsply Sirona System
FDA UDI
Zest Anchors, LLC·00840481132452·Ankylos LOCATOR R-Tx Abutment C/ 5mm
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481115141·LOCATOR F-Tx Abutment for Anklos Connection Imp...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481129360·LOCATOR R-Tx Abutment, Ankylos Conical Connecti...
ONLINE DAT II METHADONE II
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 21, 2023
SYNCHRON® ALT REAGENT, 2 X 200 TEST
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CKA·July 26, 2011
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·April 22, 2013
DUR BANTAM 10D 26X44 LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 15, 2011
CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 2, 2008
BIOLOX HEAD HIP IMPLANT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 25, 2019
UNKNOWN BIOLOX HEAD
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·February 13, 2018
CERASUL, HEAD, M/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·November 4, 2019
Site-Rite Sterile Needle Guide Kit - 20 gauge
FDA Recall
Terminated
·Bard Access Systems, Inc·Product code ITX·November 3, 2004
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
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024