61 results · 16ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.

FDA Recall
Terminated ·Cook OB/Gyn, Inc.·Product code HFE·April 2, 2009

Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22

FDA Recall
Terminated ·TriMed Inc.·Product code JDR·April 13, 2018

Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16

FDA Recall
Terminated ·TriMed Inc.·Product code JDR·April 13, 2018

Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15

FDA Recall
Terminated ·TriMed Inc.·Product code JDR·April 13, 2018

Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19

FDA Recall
Terminated ·TriMed Inc.·Product code JDR·April 13, 2018

TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

FDA Recall
Terminated ·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·October 3, 2016

Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No

FDA Recall
Open, Classified ·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·February 3, 2025

CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024

FDA Recall
Terminated ·Neuro-Fitness LLC·Product code JXK·October 29, 2007

Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

FDA Recall
Terminated ·JAS Diagnostics Inc.·Product code CGA·April 7, 2014

Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

FDA Recall
Terminated ·JAS Diagnostics Inc.·Product code GKZ·April 21, 2017

Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.

FDA Recall
Terminated ·JAS Diagnostics Inc.·Product code CFR·October 23, 2014

BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01

FDA Recall
Open, Classified ·CareFusion 303, Inc.·Product code BRY·April 5, 2023

Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

FDA Recall
Terminated ·Jas Diagnostics/Drew Scientific·Product code GKZ·March 10, 2016

INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.

FDA Recall
Terminated ·Smith & Nephew Inc·Product code JDS·February 7, 2013

Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.

FDA Recall
Terminated ·Synthes (USA) Products LLC·Product code JDS·October 14, 2013

Stryker, Gamma3S Trochanteric Nail 170, Operative Technique for Hip Fracture System.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDS·March 2, 2009

TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.

FDA Recall
Terminated ·Smith & Nephew Inc·Product code JDS·April 4, 2014

TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code JDS·June 24, 2020

BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use

FDA Recall
Terminated ·Becton Dickinson & Company·Product code GES·June 30, 2005

"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery

FDA Recall
Terminated ·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. Rd·Product code GES·August 15, 2012