FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84241–84264 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1999
ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
K993854 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 21d
Cleared Dec 06, 1999
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22
K993907 · MHD
Agilent Technologies, Inc.
General Hospital · 19d
Cleared Dec 03, 1999
SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
K981655 · DQA
Spacelabs Medical, Inc.
Anesthesiology · 571d
Cleared Dec 03, 1999
HL148 & HL168
K990807 · DXN
Health & Life Co., Ltd.
Cardiovascular · 267d
Cleared Dec 03, 1999
PRIMUS STEAM STERILIZERS
K991575 · FLE
Primus Sterilizer Co., Inc.
General Hospital · 211d
Cleared Dec 03, 1999
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A
K992992 · KPS
Toshiba America Medical Systems, In.C
Radiology · 87d
Cleared Dec 03, 1999
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED &...
K993001 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 87d
Cleared Dec 03, 1999
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM -...
K993454 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 51d
Cleared Dec 03, 1999
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
K993708 · OLX
Biomagnetic Technologies, Inc.
Neurology · 30d
Cleared Dec 03, 1999
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K993729 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Dec 03, 1999
GYRUS HYSTEROSCOPIC RESECTOSCOPE
K993749 · HIH
Gyrus Medical , Ltd.
Obstetrics & Gynecology · 28d
Cleared Dec 03, 1999
GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN...
K993752 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 28d
Cleared Dec 03, 1999
OBC-300 BREAST ARRAY COIL
K993776 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Dec 03, 1999
QWH-300 WRIST ARRAY COIL
K993819 · MOS
Mri Devices Corp.
Radiology · 23d
Cleared Dec 03, 1999
CATHETER INNOVATIONS IMPLANTABLE PORT
K993860 · LJT
Catheter Innovations, Inc.
General Hospital · 18d
Cleared Dec 02, 1999
ETHYL CHLORIDE DISPENSER
K984564 · MLY
Dukal Corp.
Physical Medicine · 344d
Cleared Dec 02, 1999
LC COMPOSITE
K991492 · EFB
Harry J. Bosworth Co.
Dental · 218d
Cleared Dec 02, 1999
AED ARTHROSCOPE
K991656 · HRX
National Advanced Endoscopy Devices,...
Orthopedic · 203d
Cleared Dec 02, 1999
ENSITE 3000 SYSTEM
K992479 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 129d
Cleared Dec 02, 1999
MS-30 FEMORAL STEM
K993043 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 83d
Cleared Dec 02, 1999
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K993102 · LTT
Dade Microscan, Inc.
Microbiology · 77d
Cleared Dec 02, 1999
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1...
K993104 · GLY
Nova Biomedical Corp.
Hematology · 77d
Cleared Dec 02, 1999
MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)
K993127 · LZA
Glovesworld Industries Sdn. Bhd.
General Hospital · 73d
Cleared Dec 02, 1999
DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING...
K993214 · KGO
Wrp Specialty Products Sdn. Bhd.
General Hospital · 69d