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
138649–138672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1987
MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.
K871990 · OLZ
Oxford Medilog, Inc.
Neurology · 134d
Cleared Oct 07, 1987
MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER
K872138 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 126d
Cleared Oct 07, 1987
CODMAN NEUROLASE LASER SYSTEM
K872179 · GEX
Codman & Shurtleff, Inc.
General & Plastic Surgery · 121d
Cleared Oct 07, 1987
MODIFIED PHADEBAS RAST/PHADEZYM RAST
K872280 · DHB
Pharmacia, Inc.
Immunology · 113d
Cleared Oct 07, 1987
OHMEDA BIOX 3740 PULSE OXIMETER
K872772 · DQA
Ohmeda Medical
Anesthesiology · 85d
Cleared Oct 07, 1987
MODEL 2240 SLAVE SCOPE
K873346 · DPS
Marquette Electronics, Inc.
Cardiovascular · 49d
Cleared Oct 07, 1987
SUTURELESS TEMPORARY EPICARDIAL PACING LEAD
K873474 · LDF
Symbion, Inc.
Cardiovascular · 37d
Cleared Oct 07, 1987
RED TOP ALLERGEN DISC
K873486 · DHB
Incstar Corp.
Immunology · 37d
Cleared Oct 07, 1987
SILENT GUARD CAT. NO. SG-10
K873488 · DTL
American Omni Medical, Inc.
Cardiovascular · 37d
Cleared Oct 07, 1987
ACA URINE DRUGS OF ABUSE CONTROL
K873539 · DIF
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 36d
Cleared Oct 07, 1987
CIBA CORNING MAGIC LITE FERRITIN
K873573 · DBF
Ciba Corning Diagnostics Corp.
Immunology · 35d
Cleared Oct 07, 1987
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K873668 · CEP
Medix Biotech, Inc.
Chemistry · 27d
Cleared Oct 07, 1987
IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT
K873676 · DHB
Incstar Corp.
Immunology · 23d
Cleared Oct 07, 1987
PULL-APART INTRODUCER (SHEATH)
K873727 · DYB
Quinton, Inc.
Cardiovascular · 28d
Cleared Oct 07, 1987
MULTICHEM ALKALINE PHOSPHATASE (S0903)
K873761 · CJE
Simmler, Inc.
Chemistry · 21d
Cleared Oct 07, 1987
QM300 TRANSFERRIN ANTIBODY PACK
K873789 · DDG
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Oct 06, 1987
SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE
K870051 · CAF
Viratek, Inc.
Anesthesiology · 273d
Cleared Oct 06, 1987
EVOPORT 300
K870567 · GWF
Dantec Electronics, Inc.
Neurology · 238d
Cleared Oct 06, 1987
(SPAG) MODEL SPAG-2 6000 SERIES
K871427 · CAF
Viratek, Inc.
Anesthesiology · 180d
Cleared Oct 06, 1987
VOCALTECH VOCAL FEEDBACK DEVICE
K871590 · KTH
Vocaltech C/O Hogan & Hartson
Ear, Nose, Throat · 165d
Cleared Oct 06, 1987
MD-104, POWERED MUSCLE STIMULATOR
K872206 · IPF
Electro Med Supply, Inc.
Physical Medicine · 120d
Cleared Oct 06, 1987
MS-108, POWERED MUSCLE STIMULATOR
K872207 · IPF
Electro Med Supply, Inc.
Physical Medicine · 120d
Cleared Oct 06, 1987
MS-112, POWERED MUSCLE STIMULATOR
K872208 · IPF
Electro Med Supply, Inc.
Physical Medicine · 120d
Cleared Oct 06, 1987
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
K872253 · HHR
Surgical Laser Technologies, Inc.
Obstetrics & Gynecology · 139d