510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
X-Pac Expandable Lumbar Cage System
Expanding Innovations, Inc.
SABER-C System
Elevation Spine
Qitexio® 4-Way Stopcock (QIT014)
Medex
AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
Integra LifeSciences Corporation
aprevo® anterior lumbar interbody fusion device with interfixation
Carlsmed, Inc.
DeltaNEC Interbody System
Nexus Spine
Instylla Delivery Kit
Instylla, Inc.
DURAMESH Mesh Suture
Msi
Normatec Go
NormaTec Industries, LP
Sure-Fine Insulin Syringes
Shina Med Corporation
Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket
Hollister Incorporated
Masimo Rad-G with Temperature
Masimo Corporation
Transit-Pellets
Medifactia AB
3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
Changsha Anxiang Medical Technology Co., Ltd.
T2 Biothreat Panel
T2biosystems, Inc.
Single Use Distal Cover MAJ-2315 (MAJ-2315)
Olympus Medical Systems Corp.
Lifetech Cardio Temporary Pacemaker
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
Initia Knee System
Kyocera Medical Technologies, Inc.
ControlSeal Electrode (ELSB)
Coapt
AdVance XP Male Sling System
Boston Scientific Corporation
Bio-Medicus Life Support Catheter and Introducer
Medtronic, Inc.
Biosteon® Screw
Biocomposites, Ltd.
Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, wi
Smith & Nephew, Inc.
Power Wheelchair (D10, D12, D15, D17, D20, D37)
Anhui Jbh Medical Apparatus Co., Ltd.
hygh-tec drainage
Creative Balloons GmbH
LUOFUCON® Collagen Particles (Collagen Wound Dressing)
Huizhou Foryou Medical Devices Co., Ltd.
OSSIOfiber Compression Screw, 3.5mm
OSSIO , Ltd.
OFNat Lubricant (L15)
Suretex Limited
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/A
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
CoolSculpting Elite System
Zeltiq Aesthetics, Inc.
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