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
144673–144696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1986
BOVINE CHEMISTRY CONTROL I.X AND II.X
K860355 · JJY
American Dade
Chemistry · 46d
Cleared Mar 17, 1986
PHENOBARBITAL TEST SYSTEM
K860365 · DLZ
Allied Instrumentation Laboratory
Toxicology · 42d
Cleared Mar 17, 1986
A-GENT LIQUID ALBUMIN
K860423 · CJW
Abbott Laboratories
Chemistry · 41d
Cleared Mar 17, 1986
PARTIAL DENTURE ALLOY
K860437 · EJH
Dentsply Intl.
Dental · 41d
Cleared Mar 17, 1986
TELESTAR I, HEARING AID
K860512 · ESD
The Florida Hearing Aid Service
Ear, Nose, Throat · 34d
Cleared Mar 17, 1986
GLUCOSE HK-60 ASSAY KIT CAT. #201-39
K860625 · CFR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Mar 17, 1986
SANDARE BCG ALBUMIN PROCEDURE
K860684 · CIX
Sandare Chemical Co., Inc.
Chemistry · 20d
Cleared Mar 17, 1986
TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS
K860690 · CDT
Catachem, Inc.
Chemistry · 20d
Cleared Mar 17, 1986
ROOT CANAL ORGANIZER
K860817 · EIK
Pacific Union Dental, Inc.
Dental · 13d
Cleared Mar 15, 1986
NON-ABSORBENT DRAPES & ABSORBENT TOWELS
K850960 · KKX
Excel Health Care Products
General Hospital · 372d
Cleared Mar 14, 1986
GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION
K851243 · LJS
Cook, Inc.
General Hospital · 381d
Cleared Mar 14, 1986
HANDI-MOVE
K854461 · ILK
T.F. Herceg, Inc.
Physical Medicine · 128d
Cleared Mar 14, 1986
SOLAR CART
K854642 · EIA
Alpine Dental Equipment Co.
Dental · 115d
Cleared Mar 14, 1986
SOLAR
K854643 · EIA
Alpine Dental Equipment Co.
Dental · 115d
Cleared Mar 14, 1986
PRIMADERM
K854740 · NAD
Absorbent Cotton Co., Inc.
General & Plastic Surgery · 109d
Cleared Mar 14, 1986
UROFLEX
K854908 · FAD
Angiomed U.S., Inc.
Gastroenterology & Urology · 95d
Cleared Mar 14, 1986
QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
K855014 · JIX
Kallestad Laboratories, Inc.
Immunology · 88d
Cleared Mar 14, 1986
KM-3 ACETABULAR COMPONENT
K855042 · JDL
Kirschner Medical Corp.
Orthopedic · 87d
Cleared Mar 14, 1986
CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS
K855091 · CDS
Sen Tech Medical Corp.
Chemistry · 84d
Cleared Mar 14, 1986
CAT-3 CATECHOLAMINE ASSAY KIT
K855214 · CHQ
Whale Scientific, Inc.
Chemistry · 74d
Cleared Mar 14, 1986
ULTRAMAX III, DIALYZER REPROCESSING DEVICE
K860026 · LIF
Medicorp, Inc.
Gastroenterology & Urology · 70d
Cleared Mar 14, 1986
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
K860245 · JFJ
Bio-Analytics Laboratories, Inc.
Chemistry · 49d
Cleared Mar 14, 1986
AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)
K860253 · CHO
Amersham Corp.
Chemistry · 49d
Cleared Mar 14, 1986
SERUM IRON & IRON BINDING REAGENT SET
K860478 · JIY
Sterling Diagnostics, Inc.
Chemistry · 35d