FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

175,468 results

72625–72648 of 175,468

Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery

Cleared Mar 20, 2003

EBI DYNAFIX COMPRESSION BONE SCREW

Orthopedic · 14d

Cleared Mar 20, 2003

INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3

Physical Medicine · 6d

Cleared Mar 19, 2003

OPTION-VF URINARY CATHETER, FV14218

Opticon Medical, Inc.

Gastroenterology & Urology · 183d

Cleared Mar 19, 2003

CHROMOCHECK PROTEIN C 25

Precision Biologic

Hematology · 106d

Cleared Mar 19, 2003

SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

Spectral Diagnostics, Inc.

Chemistry · 71d

Cleared Mar 19, 2003

HEMOSIL FACTOR XI DEFICIENT PLASMA

Instrumentation Laboratory CO

Hematology · 50d

Cleared Mar 19, 2003

WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553

Wiener Laboratories

Chemistry · 34d

Cleared Mar 19, 2003

IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM

Medtronic Surgical Navigation...

Neurology · 26d

Cleared Mar 19, 2003

ATAC CALIBRATOR

Elan Diagnostics

Chemistry · 20d

Cleared Mar 18, 2003

SILVERLEAF CONTACT WOUND DRESSING

Silverleaf Technologies, Inc.

General & Plastic Surgery · 475d

Cleared Mar 18, 2003

URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

Bayer Diagnostics Corp.

Chemistry · 264d

Cleared Mar 18, 2003

DSG RELAXER SPLINT

Sentage Corporation D/B/A/ Dental...

Cleared Mar 18, 2003

XYLOS SURGICAL MESH

Xylos Corporation

General & Plastic Surgery · 172d

Cleared Mar 18, 2003

LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP,...

Class A Enterprises, Inc.

Neurology · 153d

Cleared Mar 18, 2003

ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES

Altus Medical, Inc.

General & Plastic Surgery · 111d

Cleared Mar 18, 2003

World of Medicine Lemke GmbH

General & Plastic Surgery · 85d

Cleared Mar 18, 2003

WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006

Wiener Laboratories Saic

Chemistry · 84d

Cleared Mar 18, 2003

VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES

Vanguard Medical Concepts, Inc.

Cardiovascular · 75d

Cleared Mar 18, 2003

VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30,...

Orthopedic · 67d

Cleared Mar 18, 2003

DUOMED, SERIES 500, (MODELS ID 500, FL 500)

Neurology · 63d

Cleared Mar 18, 2003

VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7

Ortho-Clinical Diagnostics, Inc.

Immunology · 19d

Cleared Mar 17, 2003

BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER

Biopsy Sciences, LLC

General & Plastic Surgery · 136d

Cleared Mar 17, 2003

NEOSPORIN SCAR SOLUTION

Warner-Lambert Co.

General & Plastic Surgery · 90d

Cleared Mar 17, 2003

ALTON PT STEPPER

Alton Design, LLC

Radiology · 88d