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
126865–126888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 1990
V.I.P. BIRD INFANT - PEDIATRIC VENTILATOR
K895541 · CBK
Bird Products Corp.
Anesthesiology · 176d
Cleared Mar 08, 1990
ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE
K895704 · FRC
Pymah Corp., Ati Div.
General Hospital · 167d
Cleared Mar 08, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K895941 · LYY
Gim'S Trading Corp.
General Hospital · 148d
Cleared Mar 08, 1990
CARDIOCAP(TM) CMX-104 MONITOR
K896190 · DPS
Datex Division Instrumentarium Corp.
Cardiovascular · 133d
Cleared Mar 08, 1990
TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM
K896456 · JAK
Toshiba America Medical Systems, In.C
Radiology · 115d
Cleared Mar 08, 1990
POWDER-FREE DANTEX VINYL EXAMINATION GLOVES
K896527 · LYZ
Dan Co., Ltd.
General Hospital · 119d
Cleared Mar 08, 1990
LATEX PATIENT EXAMINATION GLOVES
K896672 · LYY
U.O.P. Rubber Products Sdn Bhd
General Hospital · 101d
Cleared Mar 08, 1990
LATEX PATIENT EXAMINATION GLOVES
K896673 · LYY
Alliance Rubber Products Sdn. Bhd.
General Hospital · 101d
Cleared Mar 08, 1990
STERLING STYLE 90 SURGICAL GLOVES
K896675 · KGO
Steril Rubber Sdn. Bhd.
General Hospital · 101d
Cleared Mar 08, 1990
HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS)
K896878 · EFB
Micro Motors, Inc.
Dental · 90d
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