29 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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