25 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MIROCAM CAPSULE ENDOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169601567·SPACER 2111450 OLIF25 20MM 6 DEG 14X50
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317333643·
S-Type baseplate, MR
FDA UDI
MACROMEDICS B.V.·08719425700038·S-Type baseplate, MR safe, 2P
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741114500·
MAXCUT CARBIDE BUR (10/pk) FGSS 4
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114501·MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: ...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674111450060·
StaXx® XDL System
FDA UDI
Spine Wave, Inc.·10840642100921·Cartridge Bi-Convex Lordotic Expandable Implant...
CANTATA MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SILICONE IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
Experience
FDA UDI
Gc Orthodontics America Inc.·D788111450Z0101·EXZ ROTH 018/LR5 -22T 0A 4D
Experience
FDA UDI
Gc Orthodontics America Inc.·E535111450Z0101·EXZ ROTH 018/LR5 -22T 0A 4D
STEM: QUADRA-H 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 4, 2022
BD ANGIOCATH PLUS¿ I.V. CATHETER 20GA X 1.16IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·August 23, 2022
MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NKM·September 29, 2015
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
UNKNOWN DEPUY ACS LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 13, 2011
INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·March 22, 2018
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
FDA Enforcement
Class II
·Terminated·ASO, LLC·August 14, 2013
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code JWH·August 30, 2021