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

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175,820 results
127441–127464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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