25 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.

Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

FDA Recall
Open, Classified ·EMPATICA SRL Via Enrico Stendhal·Product code POS·July 13, 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

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FBK·October 4, 2024

HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C 4) A22203C 5) A22205C 6) A22205D 7) A22206C 8) A22207C 9) A22211C 10) A22221C 11) A22222C 12) A22223C 13) A22231C 14) A22231D 15) A22251C 16) A22253C 17) A22255C 18) A22257C 19) A22258C 20) A22266C 21) A44728C 22) WA22037C 23) WA22038C 24) WA22039C 25) WA22301D 26) WA22301S 27) WA22302D 28) WA22305D 29) WA22305S 30) WA22306D 31) WA22332D 32) WA22351C 33) WA22355C 34) WA22503D 35) WA22507D 36) WA22521C 37) WA22523C 38) WA22537D 39) WA22538C 40) WA22539D 41) WA22540S 42) WA22541S 43) WA22542S 44) WA22544S 45) WA22557C 46) WA22566S 47) WA22602D 48) WA22603D 49) WA22606D 50) WA22607D 51) WA22621C 52) WA22623C 53) WA22632D 54) WA22651C 55) WA22655C 56) WA22657C 57) WA47505S 58) WA47506S 59) WA47507S 60) WA47540S 61) WA47551S 62) WA47555S 63) WA47560S 64) WA47566S

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

Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.

FDA Recall
Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FBN·September 25, 2023

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FBK·October 4, 2024

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code FBN·December 18, 2024

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FBK·October 4, 2024

Hobbs Posi-Stop Injection Needle Catalog Number: 4718

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

Hobbs Posi-Stop Injection Needle Catalog Number: 4722

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

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FBK·October 4, 2024

Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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

ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device UPN: (1)Twin Pack Box 1 M00519210; (2)Twin Pack Box 10 M00519211; (3)Single Pack Box 10 M00519231

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code FBK·October 10, 2022

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FBK·October 4, 2024

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FBK·October 4, 2024

injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge

FDA Recall
Open, Classified ·Labories Medical Technologies·Product code FBK·February 7, 2023

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FBK·October 4, 2024

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FBK·October 4, 2024

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FBK·October 4, 2024

Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code FBK·October 24, 2023