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
155305–155328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 14, 1983
ABBOTT IGE EIA
K832360 · DGC
Abbott Laboratories
Chemistry · 88d
Cleared Oct 14, 1983
CONCEPT T-TUBE
K832361 · ETD
Concept, Inc.
Ear, Nose, Throat · 88d
Cleared Oct 14, 1983
DONALDSON-TYPE VENT TUBE
K832362 · ETD
Concept, Inc.
Ear, Nose, Throat · 88d
Cleared Oct 14, 1983
LIQUID CHROMATOGRAPH 1090 SERIES
K832375 · LDM
Hewlett-Packard Co.
Toxicology · 88d
Cleared Oct 14, 1983
EASYTOUCH TROMBOPLASTIN REAGENT
K832427 · GJS
Worthington Diagnostic Systems
Chemistry · 84d
Cleared Oct 14, 1983
URO-TEX MALE EXTERNAL CATHETER
K832450 · KNX
Sierra Laboratories, Inc.
Gastroenterology & Urology · 80d