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
80929–80952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 25, 2001
IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY
K004013 · JWH
Implex Corp.
Orthopedic · 29d
Cleared Jan 24, 2001
PARSFIX CABLE-SCREW SYSTEM
K003351 · KWP
Spinal Concepts, Inc.
Orthopedic · 90d
Cleared Jan 24, 2001
ZINC PHOSPHATE CEMENT
K003427 · EMA
Rite-Dent Manufacturing Corp.
Dental · 82d
Cleared Jan 24, 2001
STIMATE N601 TENS
K003487 · GZJ
Everyway Medical Instruments Co.,Ltd
Neurology · 72d
Cleared Jan 24, 2001
KENDALL-LTP TURNER SAVE-A-LINE
K003511 · FRP
The Ludlow Company LP
General Hospital · 71d
Cleared Jan 24, 2001
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K003904 · LYY
Purna Bina Sdn Bhd
General Hospital · 36d
Cleared Jan 24, 2001
DYRACT CEM LCI COMPOMER
K003921 · EMA
Dentsply Intl.
Dental · 35d