406 results · 14ms · 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.

GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

FDA Recall
Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code IYN·May 16, 2025

Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct.

FDA Recall
Open, Classified ·GOLD STAR DISTRIBUTION INC·Product code EFW·December 26, 2025

fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once

FDA Recall
Open, Classified ·Fridababy LLC·Product code EFW·January 27, 2020

TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737

FDA Recall
Open, Classified ·Family Dollar Stores, Llc.·Product code EFW·June 23, 2022

GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system

FDA Recall
Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code IYN·May 16, 2025

PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL

FDA Recall
Open, Classified ·Pentax of America Inc·Product code PEA·January 29, 2025

PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c

FDA Recall
Open, Classified ·Pentax of America Inc·Product code PEA·January 29, 2025

Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c

FDA Recall
Open, Classified ·Pentax of America Inc·Product code PEA·January 29, 2025

Pentax Medical Video Processor; Model Number: EPK-i8020c;

FDA Recall
Open, Classified ·Pentax of America Inc·Product code PEA·July 16, 2025

Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK

FDA Recall
Open, Classified ·Pentax of America Inc·Product code FDF·July 14, 2021

Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK

FDA Recall
Open, Classified ·Pentax of America Inc·Product code FDF·July 14, 2021

BF-MP160F: EVIS EXERA Bronchofibervideoscope

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·March 8, 2022

Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·June 8, 2023

Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·June 8, 2023

Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code PKL·May 4, 2023

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·October 12, 2023

Olympus Bronchovideoscope, Models BF-XT190.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·July 27, 2023

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code GEX·December 4, 2023

ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code FAS·October 2, 2023

Colonoscope, Model Number PCF-H190L.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code FDF·January 11, 2024