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
132937–132960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1988
INTRAVASCULAR ADMINISTRATION SET
K883764 · FPA
Device Labs, Inc.
General Hospital · 104d
Cleared Dec 19, 1988
DOUBLE CLOSED URINARY DRAINAGE SYSTEM
K883886 · FCN
Knight Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 19, 1988
MODIFIED IMED GEMINI PC-1 INFUSION PUMP
K883993 · FRN
Imed Corp.
General Hospital · 90d
Cleared Dec 19, 1988
GONIOMETER AND BIOMEDICAL RECORDER SYSTEM
K884003 · KQX
Penny & Giles Blackwood , Ltd.
Neurology · 89d
Cleared Dec 19, 1988
HEARING AID WIDEX BTE
K884113 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 81d
Cleared Dec 19, 1988
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE
K884459 · GEX
Luxar Corp.
General & Plastic Surgery · 56d
Cleared Dec 19, 1988
CREATININE TEST (CREA) ITEM #65663
K884734 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Dec 16, 1988
MRL PACETTE, 450SLL
K880932 · DRO
Medical Research Laboratories, Inc.
Cardiovascular · 284d
Cleared Dec 16, 1988
AIRWAY-CIRCULATION EVALUATOR
K881483 · BTM
Resuscitation Ace, Inc.
Anesthesiology · 252d
Cleared Dec 16, 1988
EZ-SCREEN CANNABINOID/COCAINE
K883105 · DIO
Environmental Diagnostics, Inc.
Toxicology · 144d
Cleared Dec 16, 1988
T.E.N.S. UNIT SIGMA & TX-3
K883188 · GZJ
Diamond Medical Equipment, Inc.
Neurology · 141d
Cleared Dec 16, 1988
HDL-CHOLESTEROL PRECIPITATING REAGENT
K883543 · CHH
Medical Analysis Systems, Inc.
Chemistry · 119d
Cleared Dec 16, 1988
NEUROWAVE SYSTEM 2
K883557 · GWQ
Durden Enterprises, Inc.
Neurology · 119d
Cleared Dec 16, 1988
MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS
K883606 · LKD
Hewlett-Packard Co.
Anesthesiology · 115d
Cleared Dec 16, 1988
LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73
K883615 · DJY
Supelco, Inc.
Toxicology · 114d
Cleared Dec 16, 1988
NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER
K883919 · DSB
Naparima, Inc.
Cardiovascular · 91d
Cleared Dec 16, 1988
DSM-1 DOSIMETER
K884051 · CAF
S & M Instrument Co.
Anesthesiology · 81d
Cleared Dec 16, 1988
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM
K884063 · CCE
C.R. Bard, Inc.
Anesthesiology · 81d
Cleared Dec 16, 1988
THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101
K884098 · BYI
American Biosystems, Inc.
Anesthesiology · 79d
Cleared Dec 16, 1988
OXINET N-7500 PULSE OXIMETRY NETWORK
K884142 · DXH
Nellcor, Inc.
Cardiovascular · 77d
Cleared Dec 16, 1988
SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER
K884329 · DQA
Baxter Healthcare Corp
Anesthesiology · 63d
Cleared Dec 16, 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K884355 · JIY
Eastman Kodak Company
Chemistry · 60d
Cleared Dec 16, 1988
PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT
K884525 · BZO
Intertech/Ohio
Anesthesiology · 50d
Cleared Dec 16, 1988
PHOSPHORUS TEST (PHOS) ITEM #65666
K884735 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 32d