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
139753–139776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1987
VASOPULSE(TM)/MODEL 5000
K863803 · JOM
Sonicaid, Inc.
Cardiovascular · 219d
Cleared May 06, 1987
CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3
K864456 · LAS
Cala Diagnostics
Toxicology · 174d
Cleared May 06, 1987
ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD
K864690 · DRX
Multi Biosensors, Inc.
Cardiovascular · 155d
Cleared May 06, 1987
INVIVO PULSE OXIMETER, MODEL 4500
K864730 · DQA
Invivo Research Labs, Inc.
Anesthesiology · 153d
Cleared May 06, 1987
CORDAY CORONARY SINUS INFUSION CATHETER
K865074 · DQY
Retroperfusion Systems, Inc.
Cardiovascular · 128d
Cleared May 06, 1987
BONE PLATE
K870082 · HRS
Terray Manufacturing, Inc.
Orthopedic · 118d
Cleared May 06, 1987
MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER
K870301 · DRS
Medex, Inc.
Cardiovascular · 98d
Cleared May 06, 1987
AMBULATORY INFUSION PUMP DRUG RESERVOIR
K870524 · FRN
Med Fusion Systems, Inc.
General Hospital · 89d
Cleared May 06, 1987
OVU-TRAC OVULATION TIMING KIT
K870528 · LHD
Ob/Gyn Concepts, Ltd.
Obstetrics & Gynecology · 90d
Cleared May 06, 1987
THE KEEPER
K870803 · HHE
The Keeper Co.
Obstetrics & Gynecology · 68d
Cleared May 06, 1987
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR
K870829 · DTN
3M Health Care, Sarns
Cardiovascular · 64d
Cleared May 06, 1987
LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER
K870886 · LJT
Strato Medical Corp.
General Hospital · 62d
Cleared May 06, 1987
IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM
K870934 · DXG
Integrated Medical Systems, Inc.
Cardiovascular · 58d
Cleared May 06, 1987
ONGUARD 1000, CATALOG #043611-000 & 043611-001
K870976 · DTQ
Cobe Laboratories, Inc.
Cardiovascular · 57d
Cleared May 06, 1987
MODEL 8700 BIPOLAR ELECTROSURGICAL GENERATOR
K870981 · GEI
Everest Medical Corp.
General & Plastic Surgery · 57d
Cleared May 06, 1987
MVP-1500 CONTINUOUS VENTILATOR
K871009 · CBK
Medimex, Inc.
Anesthesiology · 54d
Cleared May 06, 1987
PRECIMAT(R) CRP
K871055 · DCK
Boehringer Mannheim Corp.
Immunology · 50d
Cleared May 06, 1987
PELTIERTHERAPY(C) HEAT/COLD TREATMENT
K871112 · IMF
Henley Intl.
Physical Medicine · 48d
Cleared May 06, 1987
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
K871196 · DHR
Orion Diagnostica, Inc.
Immunology · 43d
Cleared May 06, 1987
IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL
K871333 · DTB
Medtronic Vascular
Cardiovascular · 33d
Cleared May 06, 1987
NAMIC SELDINGER INTRODUCER NEEDLE
K871378 · DRC
North American Instrument Corp.
Cardiovascular · 29d
Cleared May 06, 1987
NAMIC ONE PART INTRODUCER NEEDLE
K871382 · DRC
North American Instrument Corp.
Cardiovascular · 29d
Cleared May 06, 1987
AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
K871391 · INF
Amigo Sales, Inc.
Physical Medicine · 29d
Cleared May 06, 1987
BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52
K871438 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 23d