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

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176,076 results

74737–74760 of 176,076

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

Cleared Oct 16, 2002

EB-1830T3, VIDEO BRONCHOSCOPE

Pentax Precision Instrument Corp.

Ear, Nose, Throat · 8d

Cleared Oct 15, 2002

POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE

Top Glove Medical (Thailand) Co., Ltd.

General Hospital · 117d

Cleared Oct 15, 2002

SANARUS VISICA TREATMENT SYSTEM

Sanarus Medical, Inc.

General & Plastic Surgery · 90d

Cleared Oct 15, 2002

POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE...

Qingdao Bestex Rubber & Plastic...

General Hospital · 74d

Cleared Oct 15, 2002

ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD

Bayer Diagnostics Corp.

Hematology · 64d

Cleared Oct 11, 2002

REPROCESSED IMAGING CATHETERS

Sterilmed, Inc.

Cardiovascular · 430d

Cleared Oct 11, 2002

KOWA AUTOMATED TONOMETER KT-500

Kowa Optimed, Inc.

Ophthalmic · 330d

Cleared Oct 11, 2002

QUANTUM, MODELS SR, HR, DL

General & Plastic Surgery · 210d

Cleared Oct 11, 2002

10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL

Gastroenterology & Urology · 203d

Cleared Oct 11, 2002

NEICH NM ADVANCE CATHETER SHEATH INTRODUCER

Neich Medical(Shenzhen)Company, Ltd.

Cardiovascular · 200d

Cleared Oct 11, 2002

HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300

Erecords Limited

Cardiovascular · 191d

Cleared Oct 11, 2002

OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL...

Oemedic International, Inc.

Anesthesiology · 158d

Cleared Oct 11, 2002

FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS...

Lucid Korea Co., Ltd.

Ophthalmic · 136d

Cleared Oct 11, 2002

COMFORT DREAMRIDER SCOOTER, LY-EW402

Comfort Orthopedic Co., Ltd.

Physical Medicine · 123d

Cleared Oct 11, 2002

Truevision Instruments

Ophthalmic · 121d

Cleared Oct 11, 2002

MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM)...

Merit Medical Systems, Inc.

Cardiovascular · 102d

Cleared Oct 11, 2002

STOCKERT CORONARY PERFUSION CANNULAE

Stockert Instrumente GmbH

Cardiovascular · 88d

Cleared Oct 11, 2002

ENCIRCLE LOCALIZATION DEVICE

Vivant Medical, Inc.

Gastroenterology & Urology · 88d

Cleared Oct 11, 2002

BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD

Tangshan Zhonghong Pulin Group Co., Ltd.

General Hospital · 85d

Cleared Oct 11, 2002

COMFORT WINDJOY SCOOTER, MODEL LY-EW302

Comfort Orthopedic Co., Ltd.

Physical Medicine · 81d

Cleared Oct 11, 2002

HITACHI ALTAIRE

Hitachi Medical Systems America, Inc.

Radiology · 80d

Cleared Oct 11, 2002

REUSABLE BRONCHIAL BIOPSY FORCEPS

Ballard Medical Products

Ear, Nose, Throat · 80d

Cleared Oct 11, 2002

BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST

General Hospital · 79d

Cleared Oct 11, 2002

PULPDENT SEMI-GEL ETCH

Pulpdent Corporation