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
126841–126864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1990
COULTER GLUCOSE REAGENT
K897160 · CFR
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Mar 09, 1990
COULTER ALT (GPT) REAGENT
K897163 · CKA
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Mar 09, 1990
COULTER LD (LDH-L) REAGENT
K897164 · CFJ
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Mar 09, 1990
MILENIA (TM) DIGITOXIN
K900013 · LFM
Diagnostic Products Corp.
Toxicology · 66d
Cleared Mar 09, 1990
IMMUNOTECH HDL-CHOLESTEROL TEST
K900036 · LBS
Immunotech Corp.
Chemistry · 66d
Cleared Mar 09, 1990
VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM
K900064 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 64d
Cleared Mar 09, 1990
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120 · LBR
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Mar 09, 1990
ABUSCREEN FP FOR METHAMPHETAMINE
K900143 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 57d
Cleared Mar 09, 1990
POWDER-FREE VINYL GLOVES
K900149 · LYZ
Good Glove Corp.
General Hospital · 57d
Cleared Mar 09, 1990
EZ-SCREEN:OPIATES
K900203 · DJG
Environmental Diagnostics, Inc.
Toxicology · 52d
Cleared Mar 09, 1990
MRT 50A 150MM CIRCULAR SURFACE COIL
K900284 · LNH
Toshiba America Mri, Inc.
Radiology · 46d
Cleared Mar 09, 1990
MRT 50A FLEXIBLE BODY COIL
K900285 · LNH
Toshiba America Mri, Inc.
Radiology · 46d
Cleared Mar 09, 1990
MRT 50A BRAIN QD COIL
K900288 · LNH
Toshiba America Mri, Inc.
Radiology · 46d
Cleared Mar 09, 1990
MRT 50A 100MM CIRCULAR SURFACE COIL
K900289 · LNH
Toshiba America Mri, Inc.
Radiology · 46d
Cleared Mar 09, 1990
RET-CHECK
K900484 · GJR
Streck Laboratories, Inc.
Hematology · 36d
Cleared Mar 09, 1990
VENT-TRAP CAT# WR1000
K900591 · BYH
Ventlab Corp.
Anesthesiology · 30d
Cleared Mar 09, 1990
I.V. FREEDOM CLIP
K900644 · FPA
Infection Control Products, Inc.
General Hospital · 28d
Cleared Mar 09, 1990
MRT 50A JOINT COIL
K900727 · LNH
Toshiba America Mri, Inc.
Radiology · 22d
Cleared Mar 09, 1990
MRT 50A KNEE COIL
K900728 · LNH
Toshiba America Mri, Inc.
Radiology · 22d
Cleared Mar 09, 1990
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM
K900775 · JQW
Bio-Rad
Chemistry · 17d
Cleared Mar 09, 1990
LATEX PATIENT EXAMINATION GLOVES
K900811 · LYY
Kenwell International , Ltd.
General Hospital · 16d
Cleared Mar 09, 1990
STERILE LATEX EXAMINATION GLOVE
K900868 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 14d
Cleared Mar 09, 1990
NON-STERILE LATEX PROCEDURE GLOVE
K900869 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 14d
Cleared Mar 08, 1990
UHMWPE SURGICAL MESH
K894478 · KKY
Biomet, Inc.
General & Plastic Surgery · 233d