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
128545–128568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1989
FDP COLLECTION TUBES
K896033 · JCO
Medical Diagnostic Technologies, Inc.
Hematology · 11d
Cleared Oct 26, 1989
NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER
K893643 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 164d
Cleared Oct 26, 1989
NEOS 02
K894240 · DXY
Biotronik Cardiac Pacemakers
Cardiovascular · 128d
Cleared Oct 26, 1989
DEFIB/PACING PADS
K894588 · DRO
Conmedcorp
Cardiovascular · 94d
Cleared Oct 26, 1989
PAQ10 PAPER CHART RECORDER
K894607 · DSF
Protocol Systems, Inc.
Cardiovascular · 98d
Cleared Oct 26, 1989
NON-INVASIVE BLOOD PRESSURE MODULE
K894945 · DXN
Marquette Electronics, Inc.
Cardiovascular · 84d
Cleared Oct 26, 1989
ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.
K894991 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 79d
Cleared Oct 26, 1989
COORDINATOR
K895113 · LDD
Cardiotronics, Inc.
Cardiovascular · 72d
Cleared Oct 25, 1989
NIPRO SAFELET CATH
K894371 · FOZ
Pharma-Plast USA, Inc.
General Hospital · 100d
Cleared Oct 25, 1989
DYMAX ENDOVAGINAL BIOPSY GUIDE
K894415 · HGL
Dymax Corp
Obstetrics & Gynecology · 100d
Cleared Oct 25, 1989
QUIDEL HCG TEST
K894790 · JHI
Quidel Corp.
Chemistry · 89d
Cleared Oct 25, 1989
COAT-A-COUNT (TM) HCG IRMA
K894941 · JHI
Diagnostic Products Corp.
Chemistry · 83d
Cleared Oct 25, 1989
PLASMA CATECHOLAMINES BY HPLC
K894966 · CHQ
Bio-Rad
Chemistry · 79d
Cleared Oct 25, 1989
REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE
K895046 · FPA
Pharmacia Deltec, Inc.
General Hospital · 77d
Cleared Oct 25, 1989
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104
K895528 · JJX
Helena Laboratories
Chemistry · 49d
Cleared Oct 25, 1989
N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT
K895571 · LAN
Tudor Laboratories, Inc.
Toxicology · 49d
Cleared Oct 25, 1989
TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
K895672 · JGS
Technicon Instruments Corp.
Chemistry · 35d
Cleared Oct 24, 1989
DE-BOND 200
K883418 · EKS
Scheu-Dental
Dental · 435d
Cleared Oct 24, 1989
ELECTRONIC PAIN RELIEVERS
K883811 · GZJ
Jetco of America
Neurology · 411d
Cleared Oct 24, 1989
KLEEN TEST BASIN SET
K890039 · JOL
Kleen Test Products
General Hospital · 287d
Cleared Oct 24, 1989
GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT
K890107 · FRO
Premium Plastics, Inc.
General & Plastic Surgery · 286d
Cleared Oct 24, 1989
AR-800PA RESPIRATION MODULE
K891486 · BZQ
Nihon Kohden America, Inc.
Anesthesiology · 221d
Cleared Oct 24, 1989
ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)
K892710 · EBG
Prometex, Inc.
Dental · 193d
Cleared Oct 24, 1989
METABOLIC SYSTEMS
K894154 · ISD
Cybex
Physical Medicine · 132d