Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE

Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MTS Lefamulin 0.016- 256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK

SOLVENEX I-0

FDA 510(k)

FDA Class 2 ·Dental

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·LITHOSTAR LITHOTRIPTER SHOCK WAVE SYSTEM C

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..

FDA 510(k)

FDA Class 2 ·Dental

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(R) OXYSEPT(R) 1 DISINFECTING SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(R) OXYSEPT(R) 1 DISINFECTING SOLUTION

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)

PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN

FDA 510(k)

FDA Class 2 ·Anesthesiology

RH-801/GS MODEL TRANSQ(R)1

FDA 510(k)

FDA Class 2 ·Physical Medicine

TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(R) OXYSEPT(R) 1 DISINFECTING SOL. 2 NEUT

MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)

FDA 510(k)

FDA Class 2 ·General Hospital

ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry