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
166633–166656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 1980
HDL REAGENT
K800996 · LBR
Gilford Diagnostics
Chemistry · 19d
Cleared May 14, 1980
IL SYSTEM 502 NA/K ANALYZER
K801007 · JGS
Instrumentation Laboratory CO
Chemistry · 16d
Cleared May 14, 1980
TRIGLYCERIDE REAGENT (COLOR)
K801012 · JGY
Gilford Diagnostics
Chemistry · 16d
Cleared May 14, 1980
PREZAPAK L ARTERIAL BLOOD SAMPLING KIT
K801015 · GIM
Kimble-Terumo, Inc.
Chemistry · 15d
Cleared May 14, 1980
IMMULON 1, #11-010-3350 & IMMULON 2 #--
K801018
Dynatech Laboratories, Inc.
Chemistry · 14d
Cleared May 14, 1980
ANATON
K801046 · DHN
Armkel, LLC
Immunology · 9d
Cleared May 14, 1980
ACCUDYNAMIC
K801048 · DRS
Sorensen Research
Cardiovascular · 9d
Cleared May 14, 1980
SUPRA SCOPE
K801050 · BZS
Warner-Lambert Co.
Anesthesiology · 9d
Cleared May 14, 1980
DISPOSABLE PATIENT CABLE MODEL 5807
K801064 · DSA
Daig Corp.
Cardiovascular · 8d
Cleared May 14, 1980
DELUXE HEAT WRAP/COLD WRAP
K801081 · IRT
The Gillette Company
Physical Medicine · 7d
Cleared May 14, 1980
EMPI MODEL 910S, TENS
K801112 · GZJ
Empi
Neurology · 2d
Cleared May 08, 1980
VITA LAMP, MODEL 0350
K800067 · KZF
Tensor Industries, Inc.
General Hospital · 118d
Cleared May 08, 1980
RMS 111F RESPIRATORY MONITORING SYSTEM
K800086 · BZK
The Perkin-Elmer Corp.
Anesthesiology · 115d
Cleared May 08, 1980
CLINIGUARD
K800527 · KMF
Clinipad Corp.
General & Plastic Surgery · 62d
Cleared May 08, 1980
PLASMA PRODUCTS CO., INTRA/ADMIN/SET-
K800637 · FPA
Plasma Products Co.
General Hospital · 45d
Cleared May 08, 1980
PLASMA PRODUCTS CO. NON-VENTED INTRA/SET
K800638 · FPA
Plasma Products Co.
General Hospital · 45d
Cleared May 08, 1980
ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC
K800649 · CDT
Reagents Applications, Inc.
Chemistry · 45d
Cleared May 08, 1980
QUIK-TEMP
K800666 · KPP
Liquid Crystal Products, Inc.
Gastroenterology & Urology · 43d
Cleared May 08, 1980
CANNULA, W/SHARP OBTURATOR & VERESS NEED
K800668 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 43d
Cleared May 08, 1980
FLO TEM (FLUID WARNER)
K800699 · KZL
Chroma Products, Inc.
Hematology · 41d
Cleared May 08, 1980
TA-641 TINNITUS INSTRUMENT
K800702 · KLW
Audiotrone
Ear, Nose, Throat · 41d
Cleared May 08, 1980
C-DAK TM 2800 ARTIFICIAL KIDNEY
K800704 · FJI
Cordis Corp.
Gastroenterology & Urology · 38d
Cleared May 08, 1980
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K800711 · FPA
Travenol Laboratories, S.A.
General Hospital · 38d
Cleared May 08, 1980
ENZYMATIC UREA NITROGEN REAGENT SET REVI
K800719 · CDQ
Macomb Chemical Co.
Chemistry · 38d