12 results · 15ms · 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.

Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

FDA Recall
Open, Classified ·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code OAS·October 28, 2021

Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

FDA Recall
Open, Classified ·Philips Healthcare·Product code OWB·September 24, 2021

Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FDX·December 28, 2021

Hobbs Medical Cytology Brush Catalog Number: 4204

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FDX·July 29, 2022

Hobbs Medical Cytology Brush Catalog Number: 4206

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FDX·July 29, 2022

Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA

FDA Recall
Open, Classified ·DRG International, Inc.·Product code CDX·June 4, 2025

RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

FDA Recall
Open, Classified ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021

RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100

FDA Recall
Open, Classified ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021

RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 112082090 j) 112082095 k) 112082100

FDA Recall
Open, Classified ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021

RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590

FDA Recall
Open, Classified ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021

Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934

FDA Recall
Open, Classified ·Signature Orthopaedics Europe Ltd Unit A, IDA Business & Technology Park Garrycastle Athlone Ireland·Product code MEH·October 9, 2019

Smaxel Fractional CO2 Laser, a Class IV medical laser system.

FDA Recall
Open, Classified ·IDS LTD 194 Simgung-Ro Gwangtan-Myeon Paju Korea (the Republic of)·Product code ONG·October 16, 2024