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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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