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
83041–83064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2000
KROM-ALGINATE AND ALGINATE PLUS
K000686 · ELW
Cavex Holland BV
Dental · 86d
Cleared May 25, 2000
IVC TWO MEDIUM
K000937 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 63d
Cleared May 25, 2000
IVC ONE MEDIUM
K000938 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 63d
Cleared May 25, 2000
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
K001373 · JJY
Bio-Rad
Chemistry · 24d
Cleared May 25, 2000
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085 · LCP
Abbott Laboratories
Hematology · 339d
Cleared May 25, 2000
Q-HTF, CAT# 2001
K993484 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 224d
Cleared May 25, 2000
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
K993777 · HGI
R-Group Intl.
Obstetrics & Gynecology · 199d
Cleared May 25, 2000
NELSON WATER SYSTEMS FOR HEMODIALYSIS
K993877 · FIP
Nelson Environmental Technologies, Inc.
Gastroenterology & Urology · 192d
Cleared May 24, 2000
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
K000645 · DPS
General Electric Medical Systems...
Cardiovascular · 89d
Cleared May 24, 2000
PROTON VISION
K000922 · MUJ
Varian Assoc., Inc.
Radiology · 63d
Cleared May 24, 2000
ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
K000958 · CDQ
Elan Holdings, Inc.
Chemistry · 61d
Cleared May 24, 2000
WAKO LIPASE CALIBRATOR
K001002 · JIS
Wako Chemicals USA, Inc.
Chemistry · 56d
Cleared May 24, 2000
DORNIER MEDILAS H
K001243 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 36d
Cleared May 24, 2000
CONTROL PLASMA N
K001256 · GIZ
Dade Behring, Inc.
Hematology · 35d
Cleared May 24, 2000
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
K001346 · DYB
St. Jude Medical, Inc.
Cardiovascular · 26d
Cleared May 24, 2000
BIOSCANNER TRIGLYCERIDES TEST STRIPS
K991894 · JGY
Polymer Technology Systems, Inc.
Chemistry · 356d
Cleared May 24, 2000
HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO....
K993355 · BTT
Hudson Respiratory Care, Inc.
Anesthesiology · 231d
Cleared May 23, 2000
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL...
K000108 · EMX
Bhk Holding
Ear, Nose, Throat · 130d
Cleared May 23, 2000
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
K000178 · KGO
Terang Nusa Sdn Bhd
General Hospital · 124d
Cleared May 23, 2000
NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT
K000604 · IMI
Naturopathic Laboratories...
Physical Medicine · 90d
Cleared May 23, 2000
CARDTEL, MODEL NT-100
K000609 · MWJ
Cardiac Telecommunications
Cardiovascular · 90d
Cleared May 23, 2000
SCANDINAVIAN IVF SCIENCES AB, G1.2
K000625 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 96d
Cleared May 23, 2000
SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
K000626 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 96d
Cleared May 23, 2000
REACH FEMORAL COMPONENT
K000760 · LPH
Biomet, Inc.
Orthopedic · 76d