FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
142417–142440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1986
MODEL 8900 ND:YAG LASER
K863433 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 13d
Cleared Sep 17, 1986
DUAL FORCEPLATE
K863443 · KHX
Neurocom International, Inc.
Physical Medicine · 12d
Cleared Sep 17, 1986
MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
K863485 · LLH
Marion Laboratories, Inc.
Microbiology · 8d
Cleared Sep 16, 1986
RIGHT-DAY OVULATION HOME TEST
K861354 · CEP
Leeco Diagnostics, Inc.
Chemistry · 159d
Cleared Sep 16, 1986
QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL
K861420 · JJY
Quantimetrix Corp.
Chemistry · 154d
Cleared Sep 16, 1986
VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)
K861449 · GIM
Exel Intl.
Chemistry · 152d
Cleared Sep 16, 1986
ASSERACHROM D-DI KIT
K862156 · DAP
American Bioproducts Co.
Hematology · 103d
Cleared Sep 16, 1986
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
K862371 · LCP
Bio-Rad
Hematology · 84d
Cleared Sep 16, 1986
ABBOTT RSV EIA
K862429 · GQG
Abbott Laboratories
Microbiology · 82d
Cleared Sep 16, 1986
RESPIRASTICK ENZYME IMMUNOASSAY TEST
K862475 · GTY
Orion Diagnostica, Inc.
Microbiology · 78d
Cleared Sep 16, 1986
PHOENIX SYSTEM SEVEN.
K862592 · EWO
Nicolet Biomedical Instruments
Ear, Nose, Throat · 70d
Cleared Sep 16, 1986
FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT
K862813 · CGJ
Serono Diagnostics, Inc.
Chemistry · 54d
Cleared Sep 16, 1986
VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY
K862901 · DHB
Ventrex Laboratories, Inc.
Immunology · 47d
Cleared Sep 16, 1986
FEKAL CHECK PARASITOLOGY CONTROL SLIDE
K862914 · JTR
Trend Scientific, Inc.
Microbiology · 46d
Cleared Sep 16, 1986
EMDS(TM) CALCIUM TESTPACKS, #67687/95
K863003 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Sep 16, 1986
EMDS(TM) ALBUMIN TESTPACKS, #67652/95
K863004 · CJW
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Sep 16, 1986
ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
K863099 · JJK
Abbott Laboratories
Microbiology · 34d
Cleared Sep 16, 1986
CHOLINESTERASE (PTC) REAGENT
K863202 · DIH
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Sep 16, 1986
ALT/GPT PROCEDURE
K863253 · CKA
Data Medical Associates, Inc.
Chemistry · 22d
Cleared Sep 16, 1986
BONE MARROW TRAY
K863326 · GAA
Packaging Technologies, Inc.
General & Plastic Surgery · 20d
Cleared Sep 16, 1986
CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100
K863423 · JTC
Plastic Injectors, Inc.
Microbiology · 12d
Cleared Sep 16, 1986
AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241
K863426 · JMO
American Research Products Co.
Chemistry · 12d
Cleared Sep 16, 1986
CASSETTE EMBOSSEER
K863483 · IDZ
Surgipath Medical Industries, Inc.
Pathology · 7d
Cleared Sep 15, 1986
VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN
K861808 · DSY
Cobe Laboratories, Inc.
Cardiovascular · 129d