16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GLUCOSE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496060383·DYNAMIC CCL1, SIZE S, BLU SCURO, GRADUATED COMP...
TEMP SCAN
FDA 510(k)
FDA Class 2
·General Hospital
ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
FDA 510(k)
FDA Class 2
·Orthopedic
VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBH·December 16, 2016
DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HTJ·September 14, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·September 3, 2018
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2013
NA
FDA Adverse Event
Injury
·ASCENT HEALTHCARE SOLUTIONS·Product code NLQ·June 12, 2008
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·April 15, 2011
DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HTJ·January 23, 2017
OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic ''wand'' with an absorbent wick at one end. The device is packaged in a foil pouch with desiccant. Catalog numbers are solely used for ordering by the different distributors. This OTC product is shipped as either bulk packaged product or as private labeled material labeled as follows: (1) SURE CHECK ONE STEP Pregnancy Test --- 1 TEST; MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC. MEDFORD, NY 11763 MADE IN USA; UPC 6 07158 00110 3; Catalog # PT110SURE/12 (ordered by Dean Distribution, Fred's DC Memphis, Health Enterprises, Healthcare Products, Mason Distribution, Par-Med). (2) SURE CHECK ONE STEP Pregnancy Test --- 2 TESTS; MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC. MEDFORD, NY 11763 MADE IN USA; UPC 6 07158 00112 7; Catalog # PT112/24 (Fred's DC Memphis). (3) exact pregnancy test --- Product of U.S.A./Produit des E-U. Prepared for/Prepare pour LOBLAWS INC. Montreal H4N 3L4, Toronto M4T 2S8, Calgary T2E 7S9, Canada By/Par Chembio Diagnostics Systems, Medford, New York 11763 Imported by/Import par Le Group Neuco Image Inc., Montreal, Quebec H2P 2T4 Canada; UPC 0 60383 66207 3; Catalog # PT110-N4 (Neuco). (4) exact pregnancy test --- 2 tests; Product of U.S.A./Produit des E-U. Prepared for/Prepare pour LOBLAWS INC. Montreal H4N 3L4, Toronto M4T 2S8, Calgary T2E 7S9, Canada By/Par Chembio Diagnostics Systems, Medford, New York 11763 Imported by/Import par Le Group Neuco Image Inc., Montreal, Quebec H2P 2T4 Canada; UPC 0 60383 68179; Catalog # PT112-N4 (Neuco). (5) OUR BEST NOTRE MEILLEUR ONE STEP PREGNANCY TEST (TEST DE GROSSESSE EN UNE ETAPE) --- 1 TEST --- PRODUCT OF U.S.A./PRODUIT DES E.-U. IMPORTED FOR/IMPORTE POUR: SOBEYS MISSISSAUGA, ON L4V 1W2. Manufactured by/Fabriqu par: CHEMBIO DIAGNOSTIC SYSTEMS, INC.; UPC 0 61925 57608; Catalog # PT110-N7 (Neuco). (6) BODY BASICS Pregnancy Test (Test de grossesse) --- 1 Test --- PRODUCT OF U.S.A./PRODUIT DES E.-U.A. MANUFACTURED BY/FABRIQUE PAR: CHEMBIO DIAGNOSTIC SYSTEMS, INC. IMPORTED FOR/IMPORTE POUR: THE GREAT ATLANTIC & PACIFIC COMPANY OF CANADA LTD. TORONTO, CANADA M5W1A6; UPC 0 57627 71110 9; Catalog # PT110-N6/12 (Neuco) (7) Option+ TEST DE GROSSESSE UNE ETAPE/ONE STEP PREGNANCY TEST --- Produit des E.U/Product of U.S.A. Fabrique pour/Manufactured for: UNIPRIX Inc. Montreal H1S 3G7; UPC 7 71290 05402 7; Catalog # PT110-N2 (Neuco). (8) True-Test Pregnancy Test Kit (Examen del Embarazo) One Step Testing --- 1 Test --- Distributed By: Ultras Pharmaceuticals, Inc. P.O. Box 370669 Las Vegas, NV 89137 U.S.A.; UPC 0 61406 37505 5; Catalog # PT110-R1 (Ultras). (9) Shaw's ONE-STEP Pregnancy Test ---1 TEST --- DISTRIBUTED BY SHAW'S SUPERMARKETS, INC. E. BRIDGEWATER, MA 02333, Made in USA; UPC 0 45674 65589 7; Catalog # PT110-S1 (Millbrook Distribution). (10) Harris Teeter Pregnancy Test Kits One Step Easy to use Pregnancy Test Kit --- Two Home Test Kits --- PROUDLY DISTRIBUTED BY: HARRIS TEETER MATTHEWS, NC 28105; UPC 0 72036 72061 0; Catalog # PT112-R2 (Harris Teeter). Bulk packaged product is assigned Catalog # PT110, with varying quantities (ordered by Savyon Diagnostics & Pruebas Moderna del Istmo). --- 510(k) K961965.
FDA Recall
Terminated
·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022