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
79849–79872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2001
KM-30 TENS ELECTRODE
K010543 · GXY
Katecho, Inc.
Neurology · 89d
Cleared May 23, 2001
MONARCH SPINE SYSTEM
K010576 · MNI
Depuyacromed
Orthopedic · 85d
Cleared May 23, 2001
CT SPACER
K010680 · CAF
Clinical Technologies, Inc.
Anesthesiology · 77d
Cleared May 23, 2001
BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000
K010809 · DSA
Rf Industries, Ltd.
Cardiovascular · 68d
Cleared May 23, 2001
CHEMWELL, MODEL 2900
K010877 · CIX
Awareness Technology, Inc.
Chemistry · 61d
Cleared May 23, 2001
SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,...
K011089 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 43d
Cleared May 23, 2001
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K011177 · DPS
Bci, Inc.
Cardiovascular · 36d
Cleared May 23, 2001
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
K011237 · HRS
Biomet, Inc.
Orthopedic · 30d
Cleared May 23, 2001
DCM 1.0
K011246 · MUJ
Mds Nordion
Radiology · 30d
Cleared May 23, 2001
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K011324 · DQK
Cambridge Heart, Inc.
Cardiovascular · 22d
Cleared May 23, 2001
ALOKA SSD-5500 WITH KI AND A-SMA
K011457 · IYN
Aloka Co., Ltd.
Radiology · 12d
Cleared May 22, 2001
BIOSPHERE MEDICAL INFUSION CATHETER
K003105 · DQO
Biosphere Medical
Cardiovascular · 230d
Cleared May 22, 2001
PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
K003318 · GEX
Paradigm Medical Industries, Inc.
General & Plastic Surgery · 210d
Cleared May 22, 2001
CONCENTRIC RETRIEVER, MODEL 90030
K003410 · DQY
Concentric Medical, Inc.
Cardiovascular · 201d
Cleared May 22, 2001
VHF ULTRASONIC ARC-SCAN SYSTEM
K003890 · IYO
Ultralink, LLC
Radiology · 155d
Cleared May 22, 2001
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
K003918 · DTB
Oscor, Inc.
Cardiovascular · 154d
Cleared May 22, 2001
AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES...
K003978 · NEY
Afx, Inc.
General & Plastic Surgery · 151d
Cleared May 22, 2001
PALOMAR SLP 1000
K010580 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 84d
Cleared May 22, 2001
ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR
K010711 · KKX
Advanced Surgical Concepts (Asc)
General Hospital · 74d
Cleared May 22, 2001
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
K010787 · DTD
Oscor, Inc.
Cardiovascular · 68d
Cleared May 21, 2001
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
K000733 · NBT
Inova Diagnostics, Inc.
Immunology · 441d
Cleared May 21, 2001
PELVEX HOMETRAINER
K002043 · HIR
Purdue Technology Park
Gastroenterology & Urology · 320d
Cleared May 21, 2001
VACUCATH I.V. CATHETER INTRODUCTER
K003187 · FOZ
Auto/Cath Vascular Access, Inc.
General Hospital · 222d
Cleared May 21, 2001
GEN-PROBE APTIMA COMBO 2 ASSAY
K003395 · LSL
Gen-Probe, Inc.
Microbiology · 201d