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
172777–172800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 1977
ALBUMIN TEST, HMA ALBUMIN TEST
K771259 · CIX
Hycel, Inc.
Chemistry · 42d
Cleared Aug 22, 1977
FLAME PHOTOMETER MODEL 460
K771303 · JIH
Corning Medical & Scientific
Chemistry · 38d
Cleared Aug 22, 1977
TISSUE-TEK III V.I.P.
K771308 · IEO
Miles Laboratories, Inc.
Pathology · 35d
Cleared Aug 22, 1977
CI-TROL COAGULATION CONTROLS II & III
K771346 · GGN
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 33d
Cleared Aug 22, 1977
ALLERGIST PACK SYRINGES
K771359 · FMF
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 28d
Cleared Aug 22, 1977
FLU VEN 0150
K771362 · FPA
Venospital, Inc.
General Hospital · 35d
Cleared Aug 22, 1977
AUTOZYME IMMOBILIZED ENZYME COIL
K771384 · CFR
Technicon Instruments Corp.
Chemistry · 26d
Cleared Aug 22, 1977
MONITORING LINES & FLUID ADMIN.
K771387 · FPK
Norton Performance Plastics Corp.
General Hospital · 26d
Cleared Aug 22, 1977
HISTOCHEMICAL AFB DEMONSTRATION
K771390 · ICL
Harleco
Pathology · 26d
Cleared Aug 22, 1977
MONOSTICON TEST
K771397 · KTN
Organon, Inc.
Immunology · 24d
Cleared Aug 22, 1977
IMPREGNATED DENTAL FLOSS
K771400
L.D. Caulk Co.
Dental · 24d
Cleared Aug 22, 1977
PROPHY PASTE
K771401 · EJR
L.D. Caulk Co.
Dental · 24d
Cleared Aug 22, 1977
EASE (MODIFICATION TO)
K771403 · EJJ
L.D. Caulk Co.
Dental · 24d
Cleared Aug 22, 1977
MULTI-CAVITY EQUILIBRIUM CELL
K771434
Techhnilab Instruments, Inc.
Chemistry · 21d
Cleared Aug 22, 1977
MULTISTAT III CPK TEST
K771441 · CGS
Instrumentation Laboratory CO
Chemistry · 21d
Cleared Aug 22, 1977
MULTISTAT III UREA NITROGEN TEST
K771442 · CDN
Instrumentation Laboratory CO
Chemistry · 21d
Cleared Aug 22, 1977
MULTISTAT III CREATININE TEST
K771443 · CGX
Instrumentation Laboratory CO
Chemistry · 21d
Cleared Aug 22, 1977
FLUID HANDLING DEVICE W/INPUT TUBING
K771453 · FPA
Imed Corp.
General Hospital · 19d
Cleared Aug 22, 1977
INFUSION PUMP #6202
K771478 · FRN
Roche Medical Electronics, Inc.
General Hospital · 18d
Cleared Aug 22, 1977
DUAL LAB-LITE LIGHT BOX
K771486 · DJS
Technilab
Chemistry · 21d
Cleared Aug 22, 1977
RTERIAL BLOOD SAMPLING KIT
K771489 · GJE
Bd Becton Dickinson Vacutainer...
Hematology · 17d
Cleared Aug 22, 1977
CK-MB
K771497 · JHT
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Aug 22, 1977
KEM-O-MAT
K771513 · JJF
Coulter Electronics, Inc.
Chemistry · 14d
Cleared Aug 22, 1977
HISTOCHEMICAL FERRIC IRON SET
K771524 · IAE
Harleco
Hematology · 14d