24 results
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27ms
·
Sources: EU EUDAMED, US FDA
EP-4 CLINICAL STIMULATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911040207·GELLHORN PESSARY #7
HairCheck-DT (THC)
FDA UDI
Quest Diagnostics·00868586000247·HairCheck-DT (THC) is an ELISA test kit used fo...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319700303·Turnbull Nail Nipper 5-1/2" (13.4cm), concave j...
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102070·Shaver, Open 7mm
CURVED WASHER, Ti6Al4V, 7.0 SIZE, 16mm OD
FDA UDI
ORTHO OUTCOMES, LLC·00850072364131·CURVED WASHER, Ti6Al4V, 7.0 SIZE, 16mm OD
CURVED WASHER, Ti6Al4V, 7.0 SIZE, 19mm OD
FDA UDI
ORTHO OUTCOMES, LLC·00850072364148·CURVED WASHER, Ti6Al4V, 7.0 SIZE, 19mm OD
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023901·PADDLE SPREADER, 7MM
Medline
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389027981·FENESTRATED DRAPE W/TAPE, 18 X 26
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981173517·Trial LTL, 13x12x07mm, Flat 7 Deg
POROCOAT PRODIGY HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE INSTENSIVE CARE UNIT
FDA 510(k)
FDA Class 3
·Cardiovascular
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 8, 2013
AUTOTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·April 5, 2011
TUBE, GASTROINTESTINAL (AND ACCESS)
FDA Adverse Event
Injury
·C.R. BARD, INC. (BASD)·Product code KNT·May 8, 2008
SPINAL ANESTHESIA KIT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code BSP·November 6, 2018
PRODIGY LG STAT SHT LT 12.0MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 2, 2016
PRODIGY LG STAT LNG LT 13.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·June 3, 2018
NATRELLE TE SMOOTH 133S-MV-14-T, 500CC
FDA Adverse Event
Malfunction
·ALLERGAN (COSTA RICA)·Product code LCJ·January 15, 2025
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
FDA Enforcement
Class II
·Terminated·Ondamed Inc·May 16, 2018