29 results · 29ms · Sources: EU EUDAMED, US FDA

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BLOOD PRESSURE METER, MODEL CH-658

FDA 510(k)
FDA Class 2 ·Cardiovascular

BENCO ADMIX

FDA UDI
SDI LIMITED·29336472004747·BENCO ADMIX 2SP REG 50

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814664·GENUMEDI SILVER SIZE III

EndoPilot retainer for apexcable

FDA UDI
Schlumbohm GmbH & Co. KG·04260482990817·EndoPilot retainer for apexcable

L1 MANDIBLE

FDA UDI
KLS-Martin L.P.·00888118142412·INSERT, PLATE, RECON

Vasomedical-Biox™ Model 2303 3 CH/ABP COMB Recorder

FDA UDI
VASOMEDICAL, INC.·00817980020511·Model 2303 3 CH/ABP COMB Recorder

Vasomedical-Biox™ 2303 Combined 3 Channel ECG Holter & ABP Monitor

FDA UDI
VASOMEDICAL, INC.·00817980020092·3 CH ECG Holter/ABP COMBINED Recorder

JEL-20

FDA 510(k)
FDA Class 2 ·Dental

ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY

FDA 510(k)
FDA Class 2 ·Cardiovascular

LINEAR? ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 18, 2025

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·September 29, 2003

NELLCOR PURITAN BENNET NPB-40

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·April 30, 2013

HI-TORQUE WHISPER MS

FDA Adverse Event
Death ·ABBOTT VASCULAR DEVICES·Product code DQX·July 30, 2008

ARCHITECT STAT TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code MMI·May 25, 2011

UNK - SCREWS: PHILOS

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HWC·April 20, 2026

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 7, 2015

Catalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/21/03, order 101438;

FDA Recall
Terminated ·Cardinal Health·Product code LRO·June 27, 2003

GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite Select; X-ray/computed tomography system

FDA Enforcement
Class II ·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024

I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025