21 results · 15ms · Sources: EU EUDAMED, US FDA

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Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939293052030 (Material Description Innova 5 x 200 x 130); b. H74939293052070 (Material Description Innova 5 x 200 x 75); c. H74939293062030 (Material Description Innova 6 x 200 x 130); d. H74939293062070 (Material Description Innova 6 x 200 x 75); e. H74939293072030 (Material Description Innova 7 x 200 x 130); f. H74939293072070 (Material Description Innova 7 x 200 x 75); g. H74939293082030 (Material Description Innova 8 x 200 x 130); h. H74939293082070 (Material Description Innova 8 x 200 x 75)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code NIP·November 6, 2017

Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939180051870 (Material Description Innova-EU 5 x 180 x 75); b. H74939180061870 (Material Description Innova-EU 6 x 180 x 75); c. H74939180071870 (Material Description Innova-EU 7 x 180 x 75); d. H74939180071870 (Material Description Innova-EU 8 x 180 x 75); e. H74939181051830 (Material Description Innova-EU 5 x 180 x 130); f. H74939181061830 (Material Description Innova-EU 6 x 180 x 130); g. H74939181071830 (Material Description Innova-EU 7 x 180 x 130); h. H74939181081830 (Material Description Innova-EU 8 x 180 x 130); i. H74939259051830 (Material Description Innova-China 5 x 180 x 130); j. H74939259061830 (Material Description Innova-China 6 x 180 x 130); k. H74939259071830 (Material Description Innova-China 7 x 180 x 130); l. H74939259081830 (Material Description Innova-China 8 x 180 x 130); m. H74939259081870 (Material Description Innova-China 8 x 180 x 75); n.H74939293051830 (Material Description Innova 5 x 180 x 130); o. H74939293051870 (Material Description Innova 5 x 180 x 75); p. H74939293061830 (Material Description Innova 6 x 180 x 130); q. H74939293061870 (Material Description Innova 6 x 180 x 75); r. H74939293071830 (Material Description Innova 7 x 180 x 130); s. H74939293071870 (Material Description Innova 7 x 180 x 75); t. H74939293081830 (Material Description Innova 8 x 180 x 130); u. H74939293081870 (Material Description Innova 8 x 180 x 75);

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code NIP·November 6, 2017

VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.

FDA Recall
Open, Classified ·LivaNova USA Inc·Product code LYJ·February 4, 2020

VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly

FDA Recall
Open, Classified ·LivaNova USA Inc·Product code LYJ·November 16, 2018

MediBeads Neck Wrap, Item Number 34320

FDA Recall
Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.

FDA Recall
Open, Classified ·Preat Corp·Product code EMA·February 1, 2023

IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement

FDA Recall
Open, Classified ·Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany·Product code EMA·January 25, 2024

Thermalon Eye Compress, Item Number 2434

FDA Recall
Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

Thermalon Neck Wrap, Item Number 24322

FDA Recall
Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

Thermalon Stye Compress, Item Number 24352

FDA Recall
Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

Thermalon Heating Pad, Item Number 24002

FDA Recall
Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

DENTEMP ONE STEP .077OZ, SKU 902139

FDA Recall
Open, Classified ·Family Dollar Stores, Llc.·Product code EMA·October 4, 2023

Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement

FDA Recall
Open, Classified ·Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany·Product code EMA·January 25, 2024

MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R

FDA Recall
Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

Thermalon Sinus Compress, Item Number 24332

FDA Recall
Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

Thermalon Back Wrap, Item Number 24312

FDA Recall
Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

DENTEMP ONE STEP .077OZ, SKU 902139

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

Thermalon Sinus Compress (French), Item Number 24332F

FDA Recall
Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101

FDA Recall
Open, Classified ·Binx Health, Inc. 245 1st St Ste 18 Riverview II Cambridge MA 02142-1292·Product code QEP·March 29, 2023

Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1570; 5) BIOPSY TRAY-LF, Pack Number SPEC4380; 6) BMA BX TRAY, Pack Number DYNDH1050A; 7) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 8) CATHETER ON/OFF KIT, Pack Number DT5490B; 9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 10) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 11) CIRCUMCISION TRAY, Pack Number CIT6260; 12) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 13) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 14) DELIVERY PACK, Pack Number MNS2925A; 15) DELIVERY PACK, Pack Number MNS2925B; 16) E. R. LACERATION TRAY, Pack Number DYNDL1187A; 17) FINE LACERATION KIT, Pack Number SUT19360; 18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B; 19) GENERAL UTILITY, Pack Number DYNDA2524; 20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 21) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 22) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 23) LACERATION TRAY, Pack Number DYNDL1757; 24) MYELOGRAM TRAY, Pack Number DYNDH1531; 25) OB DELIVERY SET, Pack Number MNS3355; 26) OB DELIVERY TRAY, Pack Number MNS10875; 27) OB DELIVERY TRAY, Pack Number MNS5575; 28) OB DELIVERY TRAY, Pack Number MNS10875A; 29) PICU LINE TRAY, Pack Number DYNDC1960A; 30) PORT ACCESS KIT, Pack Number DYNDC2945; 31) PORT ACCESS TRAY, Pack Number EBSI1241; 32) SINGLE TAP BLOCK TRAY, Pack Number SPEC0156A; 33) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 34) SUTURING SET, Pack Number SUT9790; 35) SUTURING SET, Pack Number SUT4020; 36) TRAY,GENERAL UTILITY, Pack Number DYNDL1422A; 37) U.A.C. TRAY, Pack Number UVT125; 38) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; 39) VAGINAL DELIVERY TRAY, Pack Number MNS11020; 40) VAGINAL DELIVERY TRAY, Pack Number MNS11020A

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MLS·April 8, 2024