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
129505–129528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1989
CADWELL FREEDOM EEG DEVICE
K894276 · GWQ
Cadwell Laboratories, Inc.
Neurology · 98d
Cleared Sep 29, 1989
UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM
K894337 · CBI
Vitaid, Ltd.
Anesthesiology · 77d
Cleared Sep 29, 1989
CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD
K894409 · IWA
Amersham Corp.
Radiology · 74d
Cleared Sep 29, 1989
DENVER PERITONEO-VENUS SHUNT
K894756 · KPM
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 29, 1989
BIO-INDUSTRY STIM POCHE(R)
K894786 · BXN
The Hader Corp.
Anesthesiology · 59d
Cleared Sep 29, 1989
TRU-TRAX
K894851 · GIO
Humagen, Inc.
Hematology · 60d
Cleared Sep 29, 1989
PRENATAL WEDGE
K895343 · JFB
Kay Ent.
Physical Medicine · 28d
Cleared Sep 29, 1989
EXCEL LATEX PATIENT EXAMINATION GLOVES
K895494 · LYY
Alpha Glove Sdn. Bhd.
General Hospital · 32d
Cleared Sep 28, 1989
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)
K891588 · LQR
Ideal Medical, Inc.
Gastroenterology & Urology · 195d
Cleared Sep 28, 1989
COAT-A-COUNT(TM) FENTANYL (TKFN1)
K891605 · DJG
Diagnostic Products Corp.
Chemistry · 192d
Cleared Sep 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892586 · LYY
Modlook Industries , Ltd.
General Hospital · 170d
Cleared Sep 28, 1989
ACL DRILL GUIDE SYSTEM
K892655 · LXI
Baxter Healthcare Corp
Orthopedic · 168d
Cleared Sep 28, 1989
MITEK DRILL GUIDE
K892904 · HXY
Mitek Surgical Products, Inc.
Orthopedic · 161d
Cleared Sep 28, 1989
KIT- CIBA CORNING L-TDM I, II, III
K893682 · DIF
Ciba Corning Diagnostics Corp.
Chemistry · 135d
Cleared Sep 28, 1989
DELTATEST (R) LIPASE II
K893718 · CET
Electro-Nucleonics, Inc.
Chemistry · 134d
Cleared Sep 28, 1989
EZ-BEAD DIGOXIN EIA KIT
K893843 · KXT
Immunotech Corp.
Toxicology · 126d
Cleared Sep 28, 1989
PLUME-AWAY SMOKE EVACUATION SYSTEM
K894038 · FYD
Laser Technologies Group, Inc.
General Hospital · 114d
Cleared Sep 28, 1989
TARGET THERAPEUTICS TRACKER LF CATHETER
K894105 · DQY
Target Therapeutics
Cardiovascular · 111d
Cleared Sep 28, 1989
VARI-SET
K894111 · LDR
Sonex Medical
General Hospital · 108d
Cleared Sep 28, 1989
BILIBLANKET PHOTOTHERAPY DEVICE
K894129 · LBI
Ohmeda Medical
General Hospital · 108d
Cleared Sep 28, 1989
OBTURATOR
K894157 · DYB
Argon Medical Corp.
Cardiovascular · 106d
Cleared Sep 28, 1989
HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL
K894160 · DZE
Artech Corp.
Dental · 106d
Cleared Sep 28, 1989
LATEX EXAMINATION GLOVES
K894193 · LYY
Hasil Getah Gulungan Pertama
General Hospital · 108d
Cleared Sep 28, 1989
ROSCO PYRR
K894221 · JTO
Pro-Lab, Inc.
Microbiology · 101d