FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125809–125832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1990
FOCUS J81F, J83F, J41F, J43F PACING LEADS
K896742 · DTB
Ela Medical, Inc.
Cardiovascular · 229d
Cleared Jul 17, 1990
SMALL VESSEL BALLOON DILATATION CATHETER
K897124 · LIT
Boston Scientific Corp
Cardiovascular · 203d
Cleared Jul 17, 1990
TRANS-PACE 100
K900220 · DTE
Synchromed Corp.
Cardiovascular · 181d
Cleared Jul 17, 1990
CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM
K900247 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 181d
Cleared Jul 17, 1990
ARTERIAL EMBOLECTOMY CATHETER
K900311 · DXE
Impra, Inc.
Cardiovascular · 176d
Cleared Jul 17, 1990
LEOCOR CORFLO(TM) PUMP
K900350 · DXK
Leocor, Inc.
Cardiovascular · 174d
Cleared Jul 17, 1990
MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER
K900460 · DQO
Novoste Corp.
Cardiovascular · 168d
Cleared Jul 17, 1990
TRAM PATIENT MONITOR
K900540 · DSI
Marquette Electronics, Inc.
Cardiovascular · 162d
Cleared Jul 17, 1990
HYDRO-SIL(TM) COATED GUIDEWIRES
K900822 · DOX
National-Standard Medical Products
Toxicology · 146d
Cleared Jul 17, 1990
TECHNICON RA-2000(TM) SYSTEM
K901410 · JJC
Technicon Instruments Corp.
Chemistry · 113d
Cleared Jul 17, 1990
PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM
K901762 · BTT
Automatic Liquid Packaging, Inc.
Anesthesiology · 90d
Cleared Jul 17, 1990
FUKUDA DENSHI MODEL HJ-310
K901889 · DXN
Fukuda Denshi USA, Inc.
Cardiovascular · 82d
Cleared Jul 17, 1990
CARDISUNY 501AB
K901947 · DPS
Graham-Field, Inc.
Cardiovascular · 78d
Cleared Jul 17, 1990
CARDISUNY 501BIII
K901948 · DPS
Graham-Field, Inc.
Cardiovascular · 78d
Cleared Jul 17, 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K902147 · DTB
Pacesetter Systems
Cardiovascular · 63d
Cleared Jul 17, 1990
MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT
K902194 · DJG
Immunotech Corp.
Toxicology · 62d
Cleared Jul 17, 1990
MODIFIED OVUGEN
K902208 · CEP
Biogenex Laboratories
Chemistry · 62d
Cleared Jul 17, 1990
LVM QUALITY CONTROL SERUM
K902235 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 61d
Cleared Jul 17, 1990
OPTI-RAY SUNGLASSES
K902414 · HQY
Opti-Ray, Inc.
Ophthalmic · 47d
Cleared Jul 17, 1990
CALCIUM:ARSENAZO III
K902476 · CJY
Amresco, Inc.
Chemistry · 42d
Cleared Jul 17, 1990
CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432
K902479 · CIC
Amresco, Inc.
Chemistry · 42d
Cleared Jul 17, 1990
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
K902560 · CJE
Roche Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Jul 17, 1990
COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER
K902671 · CAC
Cobe Laboratories, Inc.
Anesthesiology · 29d
Cleared Jul 17, 1990
HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND
K902673 · JJY
Hi Chem, Inc.
Chemistry · 29d