24 results · 27ms · Sources: EU EUDAMED, US FDA

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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