Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×

176,076 results

71617–71640 of 176,076

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

Cleared Sep 08, 2003

SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540....

Dade Behring, Inc.

Hematology · 130d

Cleared Sep 08, 2003

DURASIS DURAL SUBSTITUTE

Cook Biotech, Inc.

Neurology · 84d

Cleared Sep 08, 2003

IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED...

Sysmex America, Inc.

Hematology · 69d

Cleared Sep 08, 2003

ADVIA 60 HEMATOLOGY ANALYZER

Bayer Healthcare, LLC

Hematology · 24d

Cleared Sep 08, 2003

MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES

Matang Mfg. Sdn. Bhd.

General Hospital · 21d

Cleared Sep 05, 2003

COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E

Siemens Elema AB

Anesthesiology · 333d

Cleared Sep 05, 2003

ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES

Siemens Medical Solutions USA, Inc.

Radiology · 88d

Cleared Sep 05, 2003

TI FENESTRATED PLATE

Interpore Cross Intl.

Orthopedic · 88d

Cleared Sep 05, 2003

ENDOSCOPIC APPLICATOR

Baxter Healthcare Corp

General & Plastic Surgery · 79d

Cleared Sep 05, 2003

GEL MARK III BIOPSY SITE MARKER

General & Plastic Surgery · 74d

Cleared Sep 05, 2003

Qrs Diagnostic, LLC

Cardiovascular · 72d

Cleared Sep 05, 2003

SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE

Orthopedic · 71d

Cleared Sep 05, 2003

CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)

Cholestech Corp.

Chemistry · 66d

Cleared Sep 05, 2003

PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601

Cardiovascular · 66d

Cleared Sep 05, 2003

CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY

Access Bio Incorporate

Chemistry · 52d

Cleared Sep 05, 2003

N/T PROTEIN CONTROL

Dade Behring, Inc.

Immunology · 46d

Cleared Sep 05, 2003

BENZODIAZEPINE ENZYME IMMUNOASSAY

Lin-Zhi International, Inc.

Toxicology · 36d

Cleared Sep 05, 2003

ACUEITY MEDICAL LIGHT SOURCE

Gastroenterology & Urology · 30d

Cleared Sep 05, 2003

PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER

Precision Vascular Systems, Inc.

Cardiovascular · 23d

Cleared Sep 05, 2003

INTERLOK BIO-MODULAR HUMERAL STEMS

Orthopedic · 22d

Cleared Sep 05, 2003

ENCLOSE II ANASTOMOSIS ASSIST DEVICE

Novare Surgical Systems, Inc.

Cardiovascular · 14d

Cleared Sep 05, 2003

ONE DIMENSIONAL WATER PHANTOM, WP 1D

Wellhofer Dosimetrie

Radiology · 14d

Cleared Sep 04, 2003

DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER

Dolphin Medical, Inc.

Anesthesiology · 189d

Cleared Sep 04, 2003

TMC ELECTRICAL SCOOTER, EASY 405

Tmc Technology Corp.

Physical Medicine · 133d