16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481114526·LOCATOR F-Tx Abutment for 3.3mm CAMLOG Connecti...
Batrik Brush/White/BD 5mm/BL 50mm
FDA UDI
Batrik Medical Manufacturing Inc·00690521007901·Brush/White/BD 5mm/BL 50mm/OL 80cm - Symetric D...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481110894·LOCATOR R-Tx Abutment for 3.3mm Camlog Connecti...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00812345023350·Easyware Cuff, Ambulo ABPM 27-35 cm range
CYNOSURE PHOTOGENICA DL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 29, 2026
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019
PDS
FDA Adverse Event
Malfunction
·ETHICON, INC·Product code GAS·April 3, 2013
METRX
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK MFG·Product code LXH·May 6, 2011
HARMONIC SCALPEL GENERATOR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 17, 2008
Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25G x 8.9 cm (3-1/2'') Whitacre Spinal Needles; Assembled by Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code CAZ·March 28, 2005
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024