19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TYBR Collagen Gel
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187523·Integra® Jarit® Hibbs Chisel, 9-3/4", Straight,...
Bradshaw Medical Inc.
FDA UDI
Bradshaw Medical, Inc.·00810019930874·BIT, HEX MALE 7.0MM 1/4 SQ
Stainless Steel Goldtone Archwire
FDA UDI
Ortho Arch Company Inc·D90925010914·.021 x .025 STAINLESS STEEL ARCHES RIGHT FORM G...
Kleiner KG2 system
FDA UDI
Baat Medical Products B.V.·08720246782769·Trial
Dislocation Hook
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057992·
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·December 2, 2005
TRILLIUM BIOPUMP PLUS, MODEL BPX80T
FDA 510(k)
FDA Class 2
·Cardiovascular
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 8, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 27, 2024
PLUM 360¿ INFUSER
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FRN·February 6, 2025
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014
ADVIA CENTAUR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·September 15, 2011
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 26, 2013
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.
FDA Enforcement
Class II
·Ongoing·Spectranetics Corporation·December 25, 2024
3mensio Workstation (Vascular Fenestrated) software
FDA Enforcement
Class II
·Ongoing·PIE Medical Imaging B.V.·August 20, 2025
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 Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020