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

73969–73992 of 176,076

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

Cleared Dec 30, 2002

ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY

Medtronic Vascular

Cardiovascular · 24d

Cleared Dec 30, 2002

NARROW ASCENT INTERLOK FEMORAL COMPONENTS

Orthopedic · 24d

Cleared Dec 30, 2002

MODIFICATION TO CARDEON AEGIS CATHETER

Cardiovascular · 21d

Cleared Dec 30, 2002

BD ULTRA-FINE III PEN NEEDLE

Becton, Dickinson & CO

General Hospital · 17d

Cleared Dec 30, 2002

POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE

Wrp Asia Pacific Sdn. Bhd.

General Hospital · 14d

Cleared Dec 27, 2002

PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY

S&S Par Scientific

Radiology · 192d

Cleared Dec 27, 2002

NON-BIOABSORBABLE STAPLE

Onux Medical, Inc.

General & Plastic Surgery · 80d

Cleared Dec 27, 2002

MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM

Mitek Worldwide

Orthopedic · 79d

Cleared Dec 27, 2002

GALAXY SERIES WHEELCHAIR

Physical Medicine · 24d

Cleared Dec 26, 2002

MASTEL 1 FOLDER IMPLANTATION SYSTEM

Mastel Precision, Inc.

Ophthalmic · 132d

Cleared Dec 26, 2002

ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12

Invitrocare, Inc.

Obstetrics & Gynecology · 90d

Cleared Dec 26, 2002

INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200

Helix Medical, Inc.

Gastroenterology & Urology · 87d

Cleared Dec 26, 2002

KEGELMASTER 2000

Kegelmaster 2000 , Ltd.

Gastroenterology & Urology · 84d

Cleared Dec 26, 2002

MODIFICATION TO ALKP

Abbott Laboratories

Chemistry · 42d

Cleared Dec 24, 2002

HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089

Hygia Health Services, Inc.

Cardiovascular · 229d

Cleared Dec 24, 2002

USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY

U-Systems, Inc.

Radiology · 147d

Cleared Dec 24, 2002

TELEGRAPH HUMERAL NAIL

Fournitures Hospitalieres Industrie

Orthopedic · 85d

Cleared Dec 24, 2002

CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...

Ophthalmic · 78d

Cleared Dec 24, 2002

CHEETAH I.V.D.S., MODEL 2002P

Cheetah Medical, Inc.

Cardiovascular · 77d

Cleared Dec 24, 2002

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)

Becton, Dickinson & CO

Microbiology · 56d

Cleared Dec 24, 2002

RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE

Plus Orthopedics

Orthopedic · 54d

Cleared Dec 24, 2002

QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3

Consolidated Technology

Chemistry · 48d

Cleared Dec 24, 2002

RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS...

Hemagen Diagnostics, Inc.

Chemistry · 42d

Cleared Dec 24, 2002

AMMONIA ASSAY FOR THE ADVIA 1650

Bayer Diagnostics Corp.

Immunology · 36d