FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
127465–127488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 1990
SPIRIT
K896913 · DYW
Ormco Corp.
Dental · 87d
Cleared Mar 08, 1990
DISPOSABLE FIBER OPTIC DELIVERY SYSTEM FOR ND:YAG
K896939 · GEX
Fiber Delivery Concepts, Inc.
General & Plastic Surgery · 85d
Cleared Mar 08, 1990
SPACELABS MODEL 90480 EEG MODULE
K896942 · GWQ
Spacelabs, Inc.
Neurology · 85d
Cleared Mar 08, 1990
SITE DISPOSABLE CUTTER AND ACCESSORIES
K896943 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 85d
Cleared Mar 08, 1990
AVI MICRO 210CM INFUSION PUMP
K897013 · FRN
3M Company
General Hospital · 79d
Cleared Mar 08, 1990
ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE
K897079 · MCC
Gen-Probe, Inc.
Microbiology · 76d
Cleared Mar 08, 1990
MASKS SURGICAL DENTAL
K900088 · FXX
Kab Gloves Unltd.
General Hospital · 62d
Cleared Mar 08, 1990
MODIFIED SAFE VINYL EXAMINATION GLOVES
K900092 · LYZ
Universal Gloves Corp.
General Hospital · 59d
Cleared Mar 08, 1990
POLY PATIENT EXAMINATION GLOVES
K900152 · LYZ
Shanghai Strong Plastic Products Co.,...
General Hospital · 56d
Cleared Mar 08, 1990
MRT 50A SPINE SURFACE COIL
K900286 · LNH
Toshiba America Mri, Inc.
Radiology · 45d
Cleared Mar 08, 1990
MRT 50A CRANIO-CERVICAL COIL
K900287 · LNH
Toshiba America Mri, Inc.
Radiology · 45d
Cleared Mar 08, 1990
P2/CHEMO PLUS GLOVES
K900368 · LYY
Biosafety Systems, Inc.
General Hospital · 41d
Cleared Mar 08, 1990
ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT
K900402 · LJC
Eastman Kodak Company
Microbiology · 38d
Cleared Mar 08, 1990
LATEX PATIENT EXAMINATION GLOVES
K900499 · LYY
Premium Fit
General Hospital · 34d
Cleared Mar 08, 1990
NIL STERILE LATEX EXAMINATION GLOVES
K900648 · LYY
United Lion Rubber Industries Sdn. Bhd.
General Hospital · 27d
Cleared Mar 08, 1990
LATEX EXAMINATION GLOVES
K900650 · LYY
Shenzhen Guang JI Emulsion Products...
General Hospital · 27d
Cleared Mar 08, 1990
MODIFIED CAPTIA(R) SYPHILIS-M
K900654 · LIP
Mercia Diagnostics , Ltd.
Microbiology · 27d
Cleared Mar 08, 1990
BIODYNE INSTRUMENT WIPES
K900691 · GEC
Bio-Dyne, Inc.
General & Plastic Surgery · 23d
Cleared Mar 07, 1990
VERIMED MYOEXORCISER VERISTIM
K893220 · IPF
Verimed Holdings, Inc.
Physical Medicine · 314d
Cleared Mar 07, 1990
LE PTA CATHETER
K894250 · LIT
Baxter Healthcare Corp
Cardiovascular · 259d
Cleared Mar 07, 1990
ANGIOSCOPE
K894459 · LYK
Intramed Laboratories, Inc.
Cardiovascular · 232d
Cleared Mar 07, 1990
ORAD TOOTHBRUSH CLEANER
K895345 · EFT
Orad, Inc.
Dental · 188d
Cleared Mar 07, 1990
POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL
K895988 · EMA
Milton Hodosh, M.D.
Dental · 146d
Cleared Mar 07, 1990
ERECTION DEVICE
K896061 · LKY
Clyde Engineering Service
Gastroenterology & Urology · 140d