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
169633–169656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1979
EMIT-QUINIDINE CONTROL
K790402 · LAS
Syva Co.
Toxicology · 17d
Cleared Mar 13, 1979
MONOJECT ARTERIAL BLOOD SAMPLING DEVICE
K790196 · CBT
Sherwood Medical Industries
Anesthesiology · 47d
Cleared Mar 12, 1979
LUPO-TEC
K782129 · DHC
Armkel, LLC
Immunology · 75d
Cleared Mar 12, 1979
RIA KIT, PROLACTIN
K790003 · CFT
Cis Radiopharmaceuticals, Inc.
Chemistry · 69d
Cleared Mar 12, 1979
ACA CREATINE KINASE ISOENZYMES
K790088 · JHS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 55d
Cleared Mar 12, 1979
URIC ACID, BOUND ENZYME
K790092 · KNK
Technicon Instruments Corp.
Chemistry · 55d
Cleared Mar 12, 1979
NEPHELOMETER, MIC-2000 LASER
K790103 · JQX
Dynatech Corp.
Chemistry · 55d
Cleared Mar 12, 1979
CHORIC-SHURE
K790138 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 49d
Cleared Mar 12, 1979
ONE-WAY VALVE
K790151 · CBP
Airlife, Inc.
Anesthesiology · 59d
Cleared Mar 12, 1979
REAGENT KIT, LANCER GLUCOSE
K790197 · JJF
Sherwood Medical Industries
Chemistry · 46d
Cleared Mar 12, 1979
PLASMA, STANDARDIZED NORMAL
K790204 · JPA
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 41d
Cleared Mar 09, 1979
OXYGENATOR, COBE CATALOG #42-220
K790356 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 15d
Cleared Mar 08, 1979
STIMULATOR, MODEL 1-600 ELECTRIC NERVR
K782164 · GZJ
Ipco Corp.
Neurology · 76d
Cleared Mar 08, 1979
C/N SCREEN
K790119 · JSI
Corning Medical & Scientific
Microbiology · 44d
Cleared Mar 08, 1979
PHYTOHAEMAGGLUTININ
K790239 · KIQ
Pharmacia Fine Chemicals
Pathology · 35d
Cleared Mar 08, 1979
IMAGER, PHO/SONIC SERIES 2000
K790285 · IYO
G.D. Searle and Co.
Radiology · 27d
Cleared Mar 07, 1979
MANIFOLD, UNIVERSAL I.P.P.B
K790152 · CAF
Airlife, Inc.
Anesthesiology · 54d
Cleared Mar 07, 1979
MANIFOLD, W/CORRUGATED TUBING
K790153 · CAF
Airlife, Inc.
Anesthesiology · 54d
Cleared Mar 07, 1979
MANIFOLD, FOR DOUBLE SUPPLY
K790154 · CAF
Airlife, Inc.
Anesthesiology · 54d
Cleared Mar 07, 1979
DRAGER ORM
K790334 · BYR
Draeger Medical, Inc.
Anesthesiology · 19d
Cleared Mar 06, 1979
CATHETER, TRANSLUMINAL BALLOON
K781772 · GBA
Medi-Tech, Inc.
General & Plastic Surgery · 141d
Cleared Mar 06, 1979
KANGA PANTS
K781901 · EYQ
H.A. & J.E. Wood, Inc.
Gastroenterology & Urology · 113d
Cleared Mar 06, 1979
DIALYZER, MODEL F.M.D 150
K790001 · FJG
Hospal Medical Corp.
Gastroenterology & Urology · 63d
Cleared Mar 06, 1979
TAPE MEASURE
K790089 · FTY
Pfizer, Inc.
General & Plastic Surgery · 48d