eCarbon IBDs

FDA 510(k)

FDA Class 2 ·Orthopedic

TURBO PRIME IBD SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Ascential IBD PEEKc Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)

FDA 510(k)

FDA Class 2 ·Orthopedic

ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)

FDA 510(k)

FDA Class 2 ·Orthopedic

Endoskeleton TO Interbody Fusion Device (IBD)

FDA 510(k)

FDA Class 2 ·Orthopedic

INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL

FDA 510(k)

FDA Class 2 ·Orthopedic

Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL

FDA 510(k)

FDA Class 2 ·Orthopedic

Calprotectin, Fecal

FDA classification

FDA Class 2 ·Calprotectin, Fecal

SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System

FDA 510(k)

FDA Class 2 ·Orthopedic

Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

I3SYSTEM-ABD

FDA 510(k)

FDA Class 2 ·Radiology

MONOLISA ANTI-HAV EIA

FDA 510(k)

FDA Class 2 ·Microbiology

MONOLISA ANTI-HAV IGM EIA

FDA 510(k)

FDA Class 2 ·Microbiology

PIONEER PRO-PUMP DUAL CONTROL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PIONEER PRO-PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION

FDA 510(k)

FDA Class 2 ·Cardiovascular

1BD SOLOSHOT IX SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology