HDE approvals

All records

Every HDE record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

1. BH110018CliniMACS CD34 Reagent System
2. BH110018106CliniMACS CD34 Reagent System
3. BH220740Selective Cytopheretic Device (SCD-PED)
4. BH990200Epicel
5. BH991300Orcel
6. H000001JOMED JOSTENT CORONARY STENT GRAFT
7. H010001METACARPAL PHALANGEAL JOINT IMPLANT
8. H010002OP-1 IMPLANT
9. H010004NEUROLINK SYSTEM
10. H010005ASCENSION PIP
11. H020002NEUROFORM MICRODELIVERY STENT
12. H020003CONTEGRA PULMONARY VALVED CONDUIT
13. H020007MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS)SYSTEM
14. H020008OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS
15. H030003DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM
16. H030004HEARTSBREATH
17. H030005COAXIA NEUROFLO CATHETER
18. H040002INTACS PRESCRIPTION INSERTS FOR KERATOCONUS
19. H040004INFUSE/MASTERGRAFT CERAMIC OR INFUSE HDE KIT
20. H040005FETOSCOPY INSTRUMENT SET
21. H040006ABIOCOR IMPLANTABLE REPLACEMENT HEART
22. H050001WINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETER
23. H050003MEDTRONIC (ACTIVA)DEEP BRAIN STIMULATION FOR OCD THERAPY
24. H060001ENTERPRISE VASCULAR RECONSTRUCTIVE DEVICE AND DELIVERY SYSTEM
25. H060002IBV VALVE SYSTEM
26. H060003ONYX ANEURYSM SYSTEM, ONYX HD-500 MODEL 105-8101-500
27. H060004MESOMARK
28. H070003NEURX RA/4 DEVICE
29. H070004CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS)
30. H070005THE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDER
31. H080002MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM
32. H080004OPRA
33. H080005ELANA ARTERIOTOMY SYSTEM
34. H090002BSD-2000 HYPERTHERMIA SYSTEM
35. H100002CPAX ANEURYSM TREATMENT SYSTEM
36. H100004EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE
37. H100006NEURX DIAPHRAGM PACING SYSTEM (DPS)
38. H110002ARGUS II RETINAL PROSTHESIS SYSTEM
39. H120003XPS WITH STEEN SOLUTION PERFUSATE
40. H120005LIPOSORBER LA-15 SYSTEM
41. H130001KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN
42. H130004PLEXIMMUNE ASSAY
43. H130005LVIS INTRALUMINAL SUPPORT DEVICE
44. H130006FENIX CONTINENCE RESTORATION SYSTEM
45. H130007BAROSTIM NEO LEGACY IMPLANTABLE PULSE GENERATOR (IPG), PROGRAMMER SYSTEM,CAROTID SINUS…
46. H140001IMPELLA RP SYSTEM
47. H140005PDGFRB FISH ASSAY
48. H140006KIT D816V ASSAY
49. H150003Flourish Pediatric Esophageal Atresia Anastomosis Device
50. H160002PulseRider Aneurysm Neck Reconstruction Device
51. H170001Minimally Invasive Deformity Correction (MID-C) System
52. H170002LIPOSORBER LA-15 System
53. H170004PK Papyrus Covered Coronary Stent System
54. H180002Optune Lua
55. H190001Plasma Delipidation System (PDS-2™ System)
56. H190003Sonalleve MR-HIFU
57. H190005The Tether™ - Vertebral Body Tethering System
58. H200001Patient Specific Talus Spacer
59. H200002OncoSil™
60. H210002REFLECT™ Scoliosis Correction System
61. H210004NeVa VS
62. H220001TheraBionic P1
63. H230002River Stent System™
64. H230003restor3d Total Talus Replacement
65. H230005nAbCyte Anti-AAVRh74var HB-FE Assay
66. H230007AMDS Hybrid Prosthesis
67. H2400014WEB Medical Talar Replacement Device
68. H240004PHIL Liquid Embolic System
69. H960001HARRISON FETAL BLADDER STENT SET
70. H970001KCH FETAL BLADDER DRAINAGE CATHETER
71. H970003URO-STIM THERAPEUTIC STIMULATION UNIT
72. H970004IMMUNOSORBA PROTEIN A COLUMN AND IMMUNOSORBA PROTEIN A SEPHAROSE COLUMN
73. H970005PERMA-FLOW CORONARY GRAFT MODEL 2C10
74. H980002PROXIMAL INTERPHALANGEAL (PIP) FINGER JOINT
75. H980005NEUROCONTROL CORPORATION VOCARE BLADDER SYSTEM
76. H980006MDS NORDION THERASPHERE YTTRIUM-90 GLASS MICROSPHERES
77. H980007SHELHIGH NO-REACT PORCINE PULMONIC VALVE CONDUIT
78. H980008NEUROCONTROL VOCARE BLADDER SYSTEM
79. H990002EPICEL (CULTURED EPIDERMAL AUTOGRAFTS)
80. H990003ARTIFICIAL BOWEL SPHINCTER PROSTHESIS
81. H990012TAS ECT TEST
82. H990013COMPOSITE CULTURED SKIN
83. H990014GASTRIC ELECTRICAL STIMULATION (GES) SYSTEM