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

70777–70800 of 175,468

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

Cleared Oct 01, 2003

MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT

Vascular Solutions, Inc.

General & Plastic Surgery · 22d

Cleared Sep 30, 2003

EXTENDED RANGE HS CRP KIT, CAT NO:9200

Reference Diagnostics, Inc.

Chemistry · 267d

Cleared Sep 30, 2003

VASCUPUNCTURE PICC GUIDEWIRE

Neometrics, Inc.

Cardiovascular · 125d

Cleared Sep 30, 2003

SENOVA(R) BLOOD GLUCOSE MONITOR

Chdiagnostics, LLC

Chemistry · 85d

Cleared Sep 30, 2003

TULIP COLORSWITCH

Cavex Holland BV

Cleared Sep 30, 2003

Chemistry · 77d

Cleared Sep 30, 2003

U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE

U.S. Technologies, Inc.

General Hospital · 70d

Cleared Sep 30, 2003

Cleared Sep 30, 2003

Cleared Sep 30, 2003

MINERVA 58 ALLOY

Dentsply International

Cleared Sep 30, 2003

CERA R PLUS ALLOY

Dentsply International

Cleared Sep 30, 2003

Dentsply International

Cleared Sep 30, 2003

DURAGEN PLUS DURAL GRAFT MATRIX

Integra Lifesciences Corp.

Neurology · 28d

Cleared Sep 30, 2003

SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)

Power Medical Interventions, Inc.

General & Plastic Surgery · 28d

Cleared Sep 30, 2003

ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM

Aloka Co. Ltd USA

Radiology · 15d

Cleared Sep 29, 2003

KARL STORZ Endoscopy-America, Inc.

Gastroenterology & Urology · 427d

Cleared Sep 29, 2003

DEPUY 1 GENTAMICIN BONE CEMENT

DePuy Orthopaedics, Inc.

Orthopedic · 376d

Cleared Sep 29, 2003

AML HAIRCHECK-DT (COCAINE)

Quest Diagnostics, Inc.

Toxicology · 335d

Cleared Sep 29, 2003

Tei Biosciences, Inc.

General & Plastic Surgery · 321d

Cleared Sep 29, 2003

ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR

Elan Diagnostics

Chemistry · 270d

Cleared Sep 29, 2003

TORAYSULFONE DIALYZER, BS-L SERIES

Toray Industries (America), Inc.

Gastroenterology & Urology · 266d

Cleared Sep 29, 2003

PARAPAC 200D TRANSPORT, MODEL V200D

Anesthesiology · 200d

Cleared Sep 29, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS

Ortho-Clinical Diagnostics, Inc.

Chemistry · 181d

Cleared Sep 29, 2003

TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004

Gfe Medizintechnik GmbH

General & Plastic Surgery · 165d