Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
156145–156168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1983
GASTRIC SUMP TUBES
K833054 · KNT
Medovations, Inc.
Gastroenterology & Urology · 42d
Cleared Oct 19, 1983
BIOTRONIK DN UNIPOLAR PE-60/4-DN &
K833098 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC
K833101 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK D2K UNIPOLAR PE-60/4
K833104 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK I-UNIPOLAR PE-60/2-13
K833108 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
DEFLECTING GUIDE WIRE
K833242 · KNY
Van-Tec, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 19, 1983
QUANTAPHASE B-12-COBALMIN-FOLATE-
K833247 · CDD
Bio-Rad
Chemistry · 19d
Cleared Oct 18, 1983
LUNG POWER
K832195
Consolidated Medical Technologies
Cardiovascular · 103d
Cleared Oct 14, 1983
MONITORING KIT AMK-1
K830778 · FLS
Alternative Design Systems, Inc.
Anesthesiology · 217d
Cleared Oct 14, 1983
E-Z FIT
K831287 · KKX
Triad Medical Division
General Hospital · 177d
Cleared Oct 14, 1983
GROSHONG CATHETER, LONG TERM TYPE
K831386 · LJS
Catheter Technology Corp.
General Hospital · 169d
Cleared Oct 14, 1983
CARDIAC OUTPUT COMPUTER
K831407 · DXG
Ziehm International, Inc.
Cardiovascular · 165d
Cleared Oct 14, 1983
THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
K831424 · FJK
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 164d
Cleared Oct 14, 1983
AS 1740 INTERFACE MODULE
K831428 · DRT
Narco Scientific
Cardiovascular · 164d
Cleared Oct 14, 1983
AS 191 ECG TELEMETRY MODULE
K831429 · DPS
Narco Scientific
Cardiovascular · 164d
Cleared Oct 14, 1983
BLOOD GAS QUALITY CONTROL SOFT-86000F
K831574 · JQP
Computermate, Inc.
Hematology · 151d
Cleared Oct 14, 1983
MICROSTAR VCI
K831766 · FKX
Medionics International , Ltd.
Gastroenterology & Urology · 135d
Cleared Oct 14, 1983
EPSILON IGE TEST KIT
K831987 · DGO
Beckman Instruments, Inc.
Microbiology · 115d
Cleared Oct 14, 1983
DUAL FLOW NEEDLE
K832136 · FIE
Travenol Laboratories, S.A.
Gastroenterology & Urology · 105d
Cleared Oct 14, 1983
MICROSTAR VC1 VOLUMETRIC CYCLER
K832141 · FKX
Medionics International , Ltd.
Gastroenterology & Urology · 101d
Cleared Oct 14, 1983
HEMOCHRON THROMBOCHRONOMETER
K832189 · JBP
International Technidyne Corp.
Hematology · 98d
Cleared Oct 14, 1983
SHERIDAN/LEVI-A-SUMP
K832196 · KNT
Sheridan Catheter Corp.
Gastroenterology & Urology · 99d
Cleared Oct 14, 1983
PATIENT SELECTOR FUNCTION BLOCK
K832212 · DPS
Honeywell, Inc.
Cardiovascular · 100d
Cleared Oct 14, 1983
DIALYZER PREPARATION SYS DPS-4
K832230 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 95d