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
79801–79824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2001
MEDCOMP Z-CATH
K003682 · LJS
Medical Components, Inc.
General Hospital · 57d
Cleared Jan 26, 2001
TIANXIE
K003748 · MQX
Suzhou Tianyi Acupuncture Instruments...
General Hospital · 53d
Cleared Jan 26, 2001
MODIFICATION TO FLUROTEX SURGICAL MESH
K003906 · FTL
Bridger Biomed, Inc.
General & Plastic Surgery · 38d
Cleared Jan 26, 2001
MODIFICATION TO FLUOROTEX II SURGICAL MESH
K003917 · FTL
Bridger Biomed, Inc.
General & Plastic Surgery · 38d
Cleared Jan 26, 2001
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200...
K003934 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 37d
Cleared Jan 26, 2001
TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR
K003982 · CCK
Magnetic Resonance Equipment Corp.
Anesthesiology · 35d
Cleared Jan 26, 2001
GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT...
K010054 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 18d
Cleared Jan 26, 2001
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE
K010072 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 17d
Cleared Jan 25, 2001
GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
K001624 · MLY
Gebauer Co.
Physical Medicine · 244d
Cleared Jan 25, 2001
PVA FOAM EMBOLIZATION PARTICLES
K001678 · HCG
Surgica Corp.
Neurology · 238d
Cleared Jan 25, 2001
STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE
K001961 · DWF
Stoeckert Instrumente
Cardiovascular · 212d
Cleared Jan 25, 2001
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · DYB
Cook, Inc.
Cardiovascular · 210d
Cleared Jan 25, 2001
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
K002007 · DSY
Sulzer Carbomedics, Inc.
Cardiovascular · 206d
Cleared Jan 25, 2001
FMP METAL/METAL ACETABULAR INSERT
K003250 · KWA
Encore Orthopedics, Inc.
Orthopedic · 100d
Cleared Jan 25, 2001
WELCH ALLYN 11800 OPTHALMOSCOPE
K003376 · HLI
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared Jan 25, 2001
TWILITE, TWILITE WHITE
K003385 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 86d
Cleared Jan 25, 2001
CARDIO MONITOR CENTER VISION
K003392 · DPS
Shl Telemedicine International , Ltd.
Cardiovascular · 86d
Cleared Jan 25, 2001
PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM
K003460 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 79d
Cleared Jan 25, 2001
DENLASER, MODEL 800
K003541 · GEX
CAO Group, Inc.
General & Plastic Surgery · 70d
Cleared Jan 25, 2001
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
K003576 · DSI
Quinton, Inc.
Cardiovascular · 66d
Cleared Jan 25, 2001
HARDYDISK SULFISOXAZOLE
K003690 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Jan 25, 2001
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG,...
K003696 · DHA
Dade Behring, Inc.
Chemistry · 56d
Cleared Jan 25, 2001
ELECSYS HCG STAT CLASET II
K003941 · JIS
Roche Diagnostics Corp.
Chemistry · 35d
Cleared Jan 25, 2001
DR180+OXY
K004007 · DSH
North East Monitoring, Inc.
Cardiovascular · 30d