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
173881–173904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1977
URIN. L7-OH CORTICOSTEROID T(NON HYDRO)
K761271 · CDB
Eppendorf-Brinkmann, Inc.
Chemistry · 56d
Cleared Feb 14, 1977
AUTO CREATININE REAGENT (GILFORD 3400-E)
K761280 · CGX
Harleco
Chemistry · 56d
Cleared Feb 14, 1977
I.V. PUMP, ABBOTT/SHAW LIFECARE
K770087 · FRN
Abbott Laboratories
General Hospital · 28d
Cleared Feb 14, 1977
GAMMA 4000 SCINTILLATION COUNTER
K770088 · JJJ
Beckman Instruments, Inc.
Immunology · 28d
Cleared Feb 14, 1977
DISPOSABLE BACTERIA FILTER
K770136 · CAH
Omnicon Medical Corp.
General Hospital · 21d
Cleared Feb 14, 1977
NASO-LACRIMAL DUCT INSERT
K770194 · HNL
Concept, Inc.
Ophthalmic · 14d
Cleared Feb 14, 1977
ANALYTIX AUTO SAMPLE PREP. STA. 1600
K770210 · JQW
G.D. Searle and Co.
Immunology · 14d
Cleared Feb 14, 1977
BLOOD/FLUID WARMER MODEL DW-1000A
K770232 · BSB
Gorman Rupp Industries
Hematology · 7d
Cleared Feb 14, 1977
MODEL 880 REHABILITATION TRAINER
K770234 · ISD
Quinton, Inc.
Physical Medicine · 7d
Cleared Feb 14, 1977
DIGITAL HEART RATE METER
K770239 · DRT
Burdick Corp.
Cardiovascular · 7d
Cleared Feb 14, 1977
TREADMILL STRESS EXERCISE SYSTEM
K770240 · IOL
Burdick Corp.
Physical Medicine · 7d
Cleared Feb 14, 1977
NEONATAL T4 RIA KIT
K770241 · CDX
Diagnostic Products Corp.
Immunology · 7d
Cleared Feb 14, 1977
ELGILOY STYLET
K770243 · DRR
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Feb 14, 1977
ABDOMINAL FETAL ECG MODULE
K770245 · KXN
Mennen Greatbatch Electonics
Obstetrics & Gynecology · 7d
Cleared Feb 14, 1977
ISOLATED EEG AMPLIFIER MODULE
K770246 · GWQ
Mennen Greatbatch Electonics
Neurology · 7d
Cleared Feb 14, 1977
D.C. AMPLIFIER MODULE
K770247 · DRQ
Mennen Greatbatch Electonics
Cardiovascular · 7d
Cleared Feb 14, 1977
VENTILATOR SET - CODE 2C7109
K770249 · BTT
Travenol Laboratories, S.A.
Anesthesiology · 6d
Cleared Feb 11, 1977
REFLOMAT/REFLOTEST SYSTEM
K761148 · CGA
Boehringer Mannheim Corp.
Chemistry · 77d
Cleared Feb 11, 1977
AUTO CREATININE REAGENT (ABBOTT SYSTEM)
K761279 · CGX
Harleco
Chemistry · 53d
Cleared Feb 11, 1977
SMA REFERENCE SERUM 3
K770142 · JIX
Technicon Instruments Corp.
Chemistry · 18d
Cleared Feb 09, 1977
DATA-TOPE T3 UPTAKE PROCEDURE
K761281 · KHQ
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 51d
Cleared Feb 09, 1977
MATERNITY SUPPORTER
K770162 · FSD
R.G. Moore
General Hospital · 16d
Cleared Feb 09, 1977
O.22/UM FILTERSET W/FLASHBACK
K770183 · FPB
Abbott Laboratories
General Hospital · 13d
Cleared Feb 09, 1977
SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE
K770218 · BTO
Shiley, Inc.
Anesthesiology · 7d