PASS LP SPINAL

FDA 510(k)

FDA Class 2 ·Orthopedic

PALCERAM 49

FDA 510(k)

FDA Class 2 ·Dental

ESKA-LIBUR HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ARROW GPSCATH BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PASS LP SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

TIGER HEADLESS CANNULATED SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME

FLEX Mono Mo A-Hu Caldesmon, Cl h-CD, RTU (Dako Omnis)

FDA UDI

AGILENT TECHNOLOGIES, INC.·05700571107065·FLEX Monoclonal Mouse Anti-Human Caldesmon, Clo...

Neonatal Circuit Sing Limb Had/W (15mm Shielded Tube) & Autofill Chamber

FDA UDI

FLEXICARE MEDICAL LIMITED·05055788709633·

Fia Biomed GmbH

Importer

🇩🇪 Germany·1 Manufacturer

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA SR MRI

InHealth Technologies; Blom-Singer

FDA UDI

Freudenberg Medical, LLC·00848253003436·Post-Operative Care Kit with 10/55 Tube & Class...

HD 1224658

Certificate

MDD Annex II (excluding section 4)·H4D·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER PFO OCCLUDER

DORSAL FLEXION HOD 1" 4 (PHASE 1) 1" 4/PK

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Scott Specialties Inc·1 device

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)

NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology