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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
173569–173592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1977
NDNA IMMUNOPATH FLUORO-KIT
K770057 · DHN
Clinical Sciences, Inc.
Immunology · 84d
Cleared Apr 05, 1977
CARDIAC CATHETERIZATION LAB MONITOR SYS
K770179 · DXG
General Electric Co.
Cardiovascular · 68d
Cleared Apr 05, 1977
T3 RIA (PEG) DIAGNOSTIC KIT
K770201 · CDP
Abbott Laboratories
Toxicology · 64d
Cleared Apr 05, 1977
STERILE SUCTION CATHETER W/CONTROL
K770233 · JOL
Chesire Laboratories
General Hospital · 57d
Cleared Apr 05, 1977
OVERDOSE KIT
K770238 · FMF
American Hospital Supply Corp.
Toxicology · 57d
Cleared Apr 05, 1977
MICROFILTRATION SET MF10
K770253 · CAK
Biotest-Serum-Institut
General Hospital · 55d
Cleared Apr 05, 1977
ANALYZER, 751 KINETIC/ENDPOINT
K770306 · JJQ
Sclavo, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
MICRO/PETTOR, SMI
K770307 · JQW
Lederle Laboratories
Chemistry · 58d
Cleared Apr 05, 1977
CHEMISTRY CONTROL, NORMAL
K770310 · JJY
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
CHEMISTRY CONTROL, ABNORMAL
K770312 · JJY
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT LDH-L, ENZYME
K770313 · CFJ
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
BUN, ENZYMATIC
K770315 · CDQ
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT GOT, ENZYME
K770318 · CIT
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT CPK, ENZYME
K770319 · CGS
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
PHALDEBAS DIGOXIN RIA
K770322 · LCS
Pharmacia, Inc.
Toxicology · 47d
Cleared Apr 05, 1977
WOMB PREP KIT
K770329 · GEN
American Hospital Supply Corp.
General & Plastic Surgery · 47d
Cleared Apr 05, 1977
METER, IV PH, MODEL ZEROMATIC
K770351 · JQY
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Apr 05, 1977
TRAY, BLOOD GAS, CAT. NO. 4010
K770361 · FMF
Concord Laboratories, Inc.
General Hospital · 42d
Cleared Apr 05, 1977
STERILIZER, STEAM, CASTLE 3000
K770372 · FLE
Castle Co.
General Hospital · 39d
Cleared Apr 05, 1977
ISOLATION KIT
K770381 · LDQ
American Hospital Supply Corp.
General & Plastic Surgery · 36d
Cleared Apr 05, 1977
UNICATCH
K770387 · FMH
W.G. Whitney Corp.
General Hospital · 36d
Cleared Apr 05, 1977
CENTURION
K770419 · DXY
Johnson & Johnson Professionals, Inc.
Cardiovascular · 32d
Cleared Apr 05, 1977
UNIPOLAR LEAD CONFIGURATION CONDUCTOR
K770468 · DTB
Daig Corp.
Cardiovascular · 26d
Cleared Apr 05, 1977
3 PORT LUER
K770500 · EOQ
Unimetrics Corp.
Ear, Nose, Throat · 21d