14 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DIAPHRAGMATIC HERNIA GRAFT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Contours™ Finishing & Polishing Discs Refill Pack 3/8" Superfine
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883006259·Aluminum oxide dental finishing and polishing a...
Contours™ Finishing & Polishing Discs Refill Pack 3/8" Superfine
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172016766·Aluminum oxide dental finishing and polishing a...
MABIS
FDA UDI
D-M-S HOLDINGS, INC.·00767056330115·CALIBER ADJUSTABLE ANEROID SPHYG W/NYLON CUFF B...
ULTICARE SAFETY INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
FDA 510(k)
FDA Class 2
·Neurology
TRULIANT TIB FIT TRAY CEM SZ 3F / 3T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 8, 2022
TEMPBOND CLEAR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·June 17, 2011
CAPTIFLEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·May 29, 2013
S2S/SUR-FIT NATURA 2 PC - 2 PC UROSTOMY POUCH W/ACCUSEAL TAP
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC, INC.·Product code EXH·September 29, 2014
Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·November 25, 2020
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015