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
145561–145584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1986
I.V. DRESSING
K854040 · KMK
Consolidated Medical Equipment, Inc.
General Hospital · 99d
Cleared Jan 09, 1986
TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET
K854446 · FPA
Terumo Medical Corp.
General Hospital · 65d
Cleared Jan 09, 1986
CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I
K854562 · BRZ
Medelec Intl. Corp.
General Hospital · 56d
Cleared Jan 09, 1986
CHURCHILL-HCM VENTED IV SET
K854628 · FPA
Churchill Corp.
General Hospital · 52d
Cleared Jan 09, 1986
NORELCO DIGITAL THERMOMETER, MODEL HT 960
K854800 · FLL
Philips Park
General Hospital · 38d
Cleared Jan 09, 1986
ACUTE PERITONEAL DIALYSIS CATHETERS
K854966 · FKO
Thermedics, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 08, 1986
CYTOMEGALOVIRUS IGG EIA TEST KIT
K843189 · GQI
Labsystems, Inc.
Immunology · 513d
Cleared Jan 08, 1986
ABBOTT PHARAMACOKINETICS SYSTEMS
K851573 · NDC
Abbott Laboratories
Chemistry · 266d
Cleared Jan 08, 1986
EMERSON TRO/CATH TROCAR CATHETERS
K853132 · DRC
J. H. Emerson Co.
Cardiovascular · 166d
Cleared Jan 08, 1986
GAMBRO LUNDIA PRO 3 & 5 DIALYZER
K853406 · FJG
Gambro, Inc.
Gastroenterology & Urology · 149d
Cleared Jan 08, 1986
NAVIGATOR
K853747 · DTB
Mainsfield Scientific, Inc.
Cardiovascular · 121d
Cleared Jan 08, 1986
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
K854113 · KRI
American Bentley
Cardiovascular · 92d
Cleared Jan 08, 1986
BIO MEDICUS BIO CONSOLE 540
K854133 · DWA
Bio Medicus, Inc.
Cardiovascular · 90d
Cleared Jan 08, 1986
CMI 3000
K854233 · DRO
Cardio Management, Inc.
Cardiovascular · 79d
Cleared Jan 08, 1986
SEPACELL R-500 & SEPACELL R-500A
K854259 · CAK
Advocacy International, Ltd.
General Hospital · 77d
Cleared Jan 08, 1986
PREVIEW XT
K854282 · DSI
Cambridge Medical Instruments, Inc.
Cardiovascular · 76d
Cleared Jan 08, 1986
GEM-6, WITH COMPONENTS
K854357 · DRY
Diamond Electro-Tech, Inc.
Cardiovascular · 71d
Cleared Jan 08, 1986
HEMODIALYSIS CONCENTRATE
K854391 · FKQ
Dana Laboratories
Gastroenterology & Urology · 69d
Cleared Jan 08, 1986
HEMOSTATIC SIDEARM
K854397 · DTL
Target Therapeutics
Cardiovascular · 69d
Cleared Jan 08, 1986
O'NEIL URINARY CATHETER INTRODUCER
K854443 · KOD
Pennine Medical , Ltd.
Gastroenterology & Urology · 64d
Cleared Jan 08, 1986
ANALYST PHYSICIAN'S OFFICE PROFILER
K854523 · JJG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 57d
Cleared Jan 08, 1986
PLUME Y SET
K854951 · FIE
Hospal Medical Corp.
Gastroenterology & Urology · 29d
Cleared Jan 08, 1986
COLOSHIELD KIT
K855121 · KNT
Deknatel, Inc.
Gastroenterology & Urology · 16d
Cleared Jan 07, 1986
DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
K853038 · DRX
Bio-Detek, Inc.
Cardiovascular · 172d