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
81913–81936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 2000
MODIFICATION TO ACCUDEXA BONE DENSITOMETER
K001429 · KGI
Schick Technologies, Inc.
Radiology · 21d
Cleared May 26, 2000
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
K992668 · DYB
Innerdyne, Inc.
Cardiovascular · 291d
Cleared May 26, 2000
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K994260 · GEX
Candela Corp.
General & Plastic Surgery · 161d
Cleared May 26, 2000
IIVS INTEGRATED IMAGE VIEWING STATION
K994329 · LMD
Terarecon,Inc.
Radiology · 156d
Cleared May 25, 2000
SYNTHETIC GLASS BONE GRAFT MATERIAL
K000633 · LYC
Blue Sky Bio
Dental · 90d
Cleared May 25, 2000
VISIONARY 2000
K000639 · FSY
Burton Medical Products Corp.
General & Plastic Surgery · 90d
Cleared May 25, 2000
VISION ESTHETIC PORCELAIN SYSTEM
K000680 · EIH
Midatlantic Division of Dentrex, Inc.
Dental · 86d
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