27 results
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23ms
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Sources: EU EUDAMED, US FDA
VACPLUS SUCTION UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RingLoc® Hip System
FDA UDI
Biomet Orthopedics, LLC·00880304002296·
GOLDTECH B 2000
FDA UDI
ARGEN CORPORATION, THE·D818103535·Gold based noble metal
ILIZAROV
FDA UDI
Smith & Nephew, Inc.·03596010032379·STERILIZATION
...
Neodent
FDA UDI
JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878047056·NGS REGULAR TAPERED DRILL
Forceps, Micro, round-handle 21.0cm tip 0.4mm curved
FDA UDI
Geister Medizintechnik GmbH·04057034025727·Forceps, Micro, round-handle
21.0cm...
MEDIUM 199, CATALOG NO. 210-3535
FDA 510(k)
FDA Class 1
·Hematology
Lesser Metatarsal Shortening System
FDA UDI
Paragon 28, Inc.·00889795123671·Met Shortening Inserter, Slot, 3.5
SurgyCut
FDA UDI
U.S. SURGITECH INC.·00810014631073·
EVTOOL MODEL # V. 1.0
FDA 510(k)
FDA Class 2
·Radiology
STYLET KIT, MODELS 6254,6282,6293
FDA 510(k)
FDA Class 2
·Cardiovascular
FETAL MONITOR/CARDIOTOCOGRAM
FDA Adverse Event
Injury
·BISTOS CO., LTD.·Product code HGL·January 29, 2018
EPOLY 36MM RLC LNR MROM SZ24 ZE 24
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 11, 2021
TI LOW PROFILE SCREW 6.5X15MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 15, 2025
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·May 9, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDI·September 19, 2014
FLEXTOME CUTTING BALLOON
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·May 26, 2011
RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·December 23, 2020
RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer.
FDA Recall
Terminated
·Biomet, Inc.·Product code LPH·November 25, 2020
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