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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
77929–77952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2001
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
K011684 · PSZ
Roche Diagnostics Corp.
Microbiology · 184d
Cleared Nov 30, 2001
SERIM BLOOD LEAK TEST STRIP-2
K012115 · FJD
Serim Research Corp.
Gastroenterology & Urology · 147d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN OPIATES
K012483 · DJG
Ameditech, Inc.
Toxicology · 120d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE
K012484 · DKZ
Ameditech, Inc.
Toxicology · 120d
Cleared Nov 30, 2001
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
K012521 · GTZ
Binax, Inc.
Microbiology · 116d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN PCP
K012582 · LCM
Ameditech, Inc.
Toxicology · 112d
Cleared Nov 30, 2001
GIOTTO IMAGE
K012953 · IZH
Medx, Inc.
Radiology · 87d
Cleared Nov 30, 2001
LYMPHA PRESS PLUS DEVICE
K013331 · JOW
Mego Afek
Cardiovascular · 56d
Cleared Nov 30, 2001
IUI, MODEL 4220
K013501 · MQF
Gynetics Medical Products NV
Obstetrics & Gynecology · 39d
Cleared Nov 30, 2001
EMTRAC
K013536 · MQF
Gynetics Medical Products NV
Obstetrics & Gynecology · 38d
Cleared Nov 29, 2001
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
K001121 · CBF
Engineered Medical Technology, Inc.
Anesthesiology · 601d
Cleared Nov 29, 2001
MULTISTIM
K011308 · BXN
Pajunk GmbH
Anesthesiology · 213d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
K012359 · DBI
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K012361 · CZW
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 29, 2001
DRYSTAR, MODEL 4500M
K012941 · LMC
Agfa Corp.
Radiology · 90d
Cleared Nov 29, 2001
NEPTUNE WASTE MANAGEMENT STSTEM
K012991 · FYD
Stryker Instruments
General Hospital · 84d
Cleared Nov 29, 2001
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K013049 · LRK
Dennis R. Bailey, Dds
Dental · 79d
Cleared Nov 29, 2001
RESECTION ABLATOR
K013117 · HRX
Linvatec Corp.
Orthopedic · 72d
Cleared Nov 29, 2001
MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE
K013261 · LZA
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 59d
Cleared Nov 29, 2001
MICRO STAMPING LIGATING CLIP
K013264 · FZP
Micro Stamping Corp.
General & Plastic Surgery · 59d
Cleared Nov 29, 2001
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN...
K013324 · KGO
Tillotson Healthcare Corp.
General Hospital · 55d
Cleared Nov 29, 2001
MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR,...
K013427 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 44d
Cleared Nov 29, 2001
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM
K013432 · KTL
Immuno Concepts, Inc.
Immunology · 45d
Cleared Nov 29, 2001
POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS...
K013443 · LYY
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 43d