FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86593–86616 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K990542 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 09, 1999
BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990543 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 09, 1999
MICROPLATE NEONATAL GALT ASSAY
K990827 · KQP
Bio-Rad
Chemistry · 28d
Cleared Apr 08, 1999
ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX...
K982365 · DXC
Geister Medizin Technik GmbH
Cardiovascular · 275d
Cleared Apr 08, 1999
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
K982940 · GEX
Star Medical Technologies, Inc.
General & Plastic Surgery · 230d
Cleared Apr 08, 1999
OMEGA II MODULAR TOTAL HIP SYSTEM
K984227 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 134d
Cleared Apr 08, 1999
ACUSEAL CARDIOVASCULAR PATCH
K984526 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 108d
Cleared Apr 08, 1999
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS...
K990302 · GIR
Instrumentation Laboratory CO
Hematology · 66d
Cleared Apr 08, 1999
TRX-CG POWER TILT AND RECLINE SYSTEM
K990544 · ITI
Motion Concepts
Physical Medicine · 45d
Cleared Apr 08, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS
K990984 · JJX
Ortho-Clinical Diagnostics, Inc.
Immunology · 15d
Cleared Apr 07, 1999
ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65
K981191 · DQY
Intratherapeutics, Inc.
Cardiovascular · 370d
Cleared Apr 07, 1999
SMARTVENT 201 PORTABLE VENTILATOR
K981668 · CBK
Versamed , Ltd.
Anesthesiology · 331d
Cleared Apr 07, 1999
EMS MOUTH TO MASK RESUSCITATORS
K983919 · CBP
Engineered Medical Systems
Anesthesiology · 154d
Cleared Apr 07, 1999
CLEARPLAN EASY HOME PREGNANCY TEST
K990262 · LCX
Unipath , Ltd.
Chemistry · 70d
Cleared Apr 07, 1999
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
K990587 · DHR
Bio-Rad
Immunology · 43d
Cleared Apr 07, 1999
MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
K990888 · JJY
Bio-Rad
Chemistry · 28d
Cleared Apr 07, 1999
SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED...
K990970 · IYN
Medison America, Inc.
Radiology · 15d
Cleared Apr 06, 1999
SHARPS COLLECTION CONTAINER - SAF-T-SHELL
K982029 · FMI
American Medical Mfg., Inc.
General Hospital · 301d
Cleared Apr 06, 1999
MEDEX 3000 SERIES SYRINGE INFUSION PUMP
K982640 · FRN
Medex, Inc.
General Hospital · 251d
Cleared Apr 06, 1999
'ECURLINE UMBILICAL CORD CLAMP #3500
K990737 · HFW
Precision Dynamics Corp.
Obstetrics & Gynecology · 32d
Cleared Apr 06, 1999
IPS D.SIGN PORCELAIN
K990817 · EIH
Ivoclar North America, Inc.
Dental · 26d
Cleared Apr 06, 1999
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
K990863 · KNT
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 21d
Cleared Apr 06, 1999
IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
K990886 · DCK
Diagnostic Products Corp.
Immunology · 20d
Cleared Apr 06, 1999
PRODIGY 4
K990898 · EBF
Sybron Dental Specialties, Inc.
Dental · 19d