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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
139969–139992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 1987
VIP'S PROPHYLACTICS, NATURAL, ANATOMIC & FEMINA
K871300 · HIS
Professional Pharmacy West, Inc.
Obstetrics & Gynecology · 68d
Cleared Jun 08, 1987
BOWEN REUSEABLE/DISPOSABLE ELECTRODE
K871325 · DRX
Bowen & Company, Inc.
Cardiovascular · 66d
Cleared Jun 08, 1987
PREBYPASS FILTER
K871350 · KRJ
American Omni Medical, Inc.
Cardiovascular · 63d
Cleared Jun 08, 1987
OXIMETER
K871353 · DQA
Radiometer America, Inc.
Anesthesiology · 63d
Cleared Jun 08, 1987
COSMETIC SINGLE SPAN BRIDGE
K871439 · EGG
Cosmetic Dental Technologies, Inc.
Dental · 56d
Cleared Jun 08, 1987
TELSTAR MODEL FS HEARING AID
K871520 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 49d
Cleared Jun 08, 1987
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
K871569 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 45d
Cleared Jun 08, 1987
TMJ CANNULA SET
K871648 · DZI
Aspen Laboratories, Inc.
Dental · 41d
Cleared Jun 08, 1987
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
K871680 · LAN
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Jun 08, 1987
RIBBED CUSHION MASK
K871851 · BSJ
Engineered Medical Systems
Anesthesiology · 27d
Cleared Jun 08, 1987
ESKA-HERRMANN TRACHEOSTOMY VALVE
K871885 · EWL
C.R. Bard, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 08, 1987
BTE HEARING AID OTICON MODEL E30P
K872017 · ESD
Oticon Corp.
Ear, Nose, Throat · 13d
Cleared Jun 05, 1987
TRI-SERVICE OMV VAPORIZER
K864589 · BSZ
Bear Medical Systems, Inc.
Anesthesiology · 196d
Cleared Jun 05, 1987
DORROS(TM) SMALL VESSEL PTA CATHETER
K870460 · DXN
C.R. Bard, Inc.
Cardiovascular · 122d
Cleared Jun 05, 1987
AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G
K870742 · KMJ
Span-America Medical Systems, Inc.
General Hospital · 100d
Cleared Jun 05, 1987
CONSULTANT BODY COMPOSITION ANALYZER
K871040 · DSB
Body Composition Analog, Inc.
Cardiovascular · 80d
Cleared Jun 05, 1987
DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER
K871149 · DRT
Iontec Corp.
Cardiovascular · 74d
Cleared Jun 05, 1987
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
K871208 · DYB
Pacesetter Systems
Cardiovascular · 72d
Cleared Jun 05, 1987
CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300
K871221 · DRY
Cardiovascular Devices, Inc.
Cardiovascular · 70d
Cleared Jun 05, 1987
ACUSON PHYSIOLOGICAL CONTROL MODULE
K871239 · DPS
Acuson Computed Sonography
Cardiovascular · 70d
Cleared Jun 05, 1987
COCAINE METABOLITE ENZYME IMMUNOASSAY KIT
K871305 · DIO
General Diagnostics
Toxicology · 65d
Cleared Jun 05, 1987
M-1 PRESSURE MONITOR
K871336 · CAP
Bio-Med Devices, Inc.
Anesthesiology · 63d
Cleared Jun 05, 1987
M-2 OXYGEN/TEMPERATURE MONITOR
K871337 · CCL
Bio-Med Devices, Inc.
Anesthesiology · 63d
Cleared Jun 05, 1987
MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE
K871363 · DXN
Quinton, Inc.
Cardiovascular · 59d