FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
78721–78744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 2001
VIVA
K011480 · HIS
Richter Rubber Technology Sdn. Bhd.
Obstetrics & Gynecology · 10d
Cleared May 23, 2001
VEGA ULTRASONIC NEBULIZER
K002831 · CAF
Vega Technologies, Inc.
Anesthesiology · 254d
Cleared May 23, 2001
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
K003251 · BSZ
Blease Medical Equipment , Ltd.
Anesthesiology · 218d
Cleared May 23, 2001
WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL...
K003618 · NDD
Whiteside Biomechanics, Inc.
Orthopedic · 182d
Cleared May 23, 2001
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K004049 · LPL
Optech, Inc.
Ophthalmic · 145d
Cleared May 23, 2001
SYNTHES ANTEROLATERAL CALCANEAL PLATE
K010518 · KTT
Synthes (Usa)
Orthopedic · 90d
Cleared May 23, 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · HWC
Arthrex, Inc.
Orthopedic · 90d
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