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

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175,820 results
51985–52008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2009
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C
K092456 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 74d
Cleared Oct 23, 2009
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
K092919 · LON
Siemens Healthcare Diagnostics
Microbiology · 30d
Cleared Oct 23, 2009
JAZZY FRONTIE
K092961 · ITI
Pride Mobility Products Corp.
Physical Medicine · 28d
Cleared Oct 23, 2009
AMD 6605 TENS/NMES
K092990 · GZJ
Advantageous Medical Devices, LLC
Neurology · 25d
Cleared Oct 23, 2009
BIS QUATRO SENSOR
K093183 · GXY
Aspect Medical Systems, Inc.
Neurology · 14d
Cleared Oct 22, 2009
THERAFORM BILAYER
K090823 · KGN
Sewon Cellontech Co., Ltd.
General & Plastic Surgery · 210d
Cleared Oct 22, 2009
EQUALSHIELD LUER LOCK CONNECTOR PAIR
K091389 · LHI
Plastmed, Ltd.
General Hospital · 164d
Cleared Oct 22, 2009
MEDEOR MATRIX, MODELS 30010-XX (HYDRATED)
K091499 · FTM
Kensey Nash Corp.
General & Plastic Surgery · 154d
Cleared Oct 22, 2009
PC ECG, MODEL SE-1010
K092010 · DPS
Edan Instruments, Inc.
Cardiovascular · 108d
Cleared Oct 22, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK)
K092301 · LYZ
Bettercare Plastic Products Co., Ltd.
General Hospital · 85d
Cleared Oct 22, 2009
ZIROX
K092630 · EIH
Zencera, Inc.
Dental · 56d
Cleared Oct 22, 2009
DEBP
K092783 · HGX
Enko , Ltd.
Obstetrics & Gynecology · 42d
Cleared Oct 21, 2009
RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR
K082756 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 397d
Cleared Oct 21, 2009
NEUROCALM MODEL 1 AND 2
K090866 · GZJ
Neuromed Devices, Inc.
Neurology · 204d
Cleared Oct 21, 2009
ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING
K091354 · FRO
Acrymed, Inc.
General & Plastic Surgery · 166d
Cleared Oct 21, 2009
VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH
K091414 · DXN
Biocare Corp.
Cardiovascular · 161d
Cleared Oct 21, 2009
REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES
K092101 · DQA
Nonin Medical, Inc.
Anesthesiology · 99d
Cleared Oct 21, 2009
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE,...
K092283 · DFZ
Siemens Healthcare Diagnostics
Immunology · 84d
Cleared Oct 21, 2009
VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR
K092294 · LYZ
Bettercare Plastic Products Co., Ltd.
General Hospital · 84d
Cleared Oct 21, 2009
POWDER FREE EXAMINATION GLOVE
K092296 · LYZ
Bettercare Plastic Products Co., Ltd.
General Hospital · 84d
Cleared Oct 21, 2009
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW,...
K092411 · LZA
Shen Wei (Usa), Inc.
General Hospital · 75d
Cleared Oct 21, 2009
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
K092425 · OWQ
Ascent Healthcare Solutions
Cardiovascular · 75d
Cleared Oct 21, 2009
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH...
K092492 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 69d
Cleared Oct 21, 2009
LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND...
K092604 · DXQ
Trimline Medical Products Corp.
Cardiovascular · 57d