Orthosis, Cranial, Laser Scan

FDA classification

FDA Class 2 ·Orthosis, Cranial, Laser Scan

Closed Loop Auto Titration Device For Oral Appliances

FDA classification

FDA Class 2 ·Closed Loop Auto Titration Device For Oral Appliances

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

FDA classification

FDA Class 2 ·Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

FDA classification

FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Fracture

21-Hydroxylase Antibody (21-Ohab)

FDA classification

FDA Class 2 ·21-Hydroxylase Antibody (21-Ohab)

Magnetic Compression Anastomosis System

FDA classification

FDA Class 2 ·Magnetic Compression Anastomosis System

Conformal Brachytherapy Source

FDA classification

FDA Class 2 ·Conformal Brachytherapy Source

Surgical Film

FDA classification

FDA Class 2 ·Surgical Film

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

FDA classification

FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

FDA Class 2 ·Device To Detect Microbial Colonization Directly From Clinical Specimens.

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

FDA classification

FDA Class 2 ·Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Complete Gene Expression Profiling Accessory Reagents

FDA classification

FDA Class 2 ·Complete Gene Expression Profiling Accessory Reagents

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FDA classification

FDA Class 2 ·Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Alternate Controller Enabled Insulin Infusion Pump

FDA classification

FDA Class 2 ·Alternate Controller Enabled Insulin Infusion Pump

ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE

FDA 510(k)

FDA Class 2 ·General Hospital

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

FDA classification

FDA Class 2 ·Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

Laparoscope And Accessories, Gynecologic, Reprocessed

FDA classification

FDA Class 2 ·Laparoscope And Accessories, Gynecologic, Reprocessed

Antigen, Invasive Fungal Pathogens

FDA classification

FDA Class 2 ·Antigen, Invasive Fungal Pathogens

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

FDA classification

FDA Class 2 ·Plate, Bone, Growth Control, Pediatric, Epiphysiodesis