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
104137–104160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1995
HP-FAST
K944903 · LYR
Gi Supply
Microbiology · 198d
Cleared Apr 20, 1995
ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM
K945271 · JJE
Bio-Chem Laboratory Systems, Inc.
Chemistry · 184d
Cleared Apr 20, 1995
MRT-50 QD BODY COIL
K945875 · LNH
Toshiba America Mri, Inc.
Radiology · 140d
Cleared Apr 20, 1995
TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
K950353 · JJE
Miles, Inc.
Chemistry · 80d
Cleared Apr 20, 1995
FORAMATRON IV
K950857 · LQY
Parkell, Inc.
Dental · 52d
Cleared Apr 20, 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950936 · DZE
Steri-Oss, Inc.
Dental · 50d
Cleared Apr 20, 1995
MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2
K951057 · DCK
Medical Analysis Systems, Inc.
Immunology · 44d
Cleared Apr 20, 1995
BIONIKE A/Q PREGNANCY TEST
K951136 · JHI
Charlton Assoc.
Chemistry · 38d
Cleared Apr 20, 1995
VIGIL MULTICHEK CONTROLS
K951170 · JJY
Beckman Instruments, Inc.
Chemistry · 36d
Cleared Apr 20, 1995
KOORDINAT M
K951176 · IXR
Siemens Medical Solutions USA, Inc.
Radiology · 36d
Cleared Apr 20, 1995
GIROC
K951235 · DYH
Health-Dent Intl., Inc.
Dental · 31d
Cleared Apr 20, 1995
QUANTITATE ENZYME VERIFIER SET
K951293 · JJT
Beckman Instruments, Inc.
Chemistry · 29d
Cleared Apr 19, 1995
HOLTER FOR WINDOWS
K930564 · DQK
North East Monitoring, Inc.
Cardiovascular · 805d
Cleared Apr 19, 1995
CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION
K933450 · DRF
Electro-Catheter Corp.
Cardiovascular · 646d
Cleared Apr 19, 1995
OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION
K933451 · DRF
Electro-Catheter Corp.
Cardiovascular · 646d
Cleared Apr 19, 1995
UPSCAN
K933512 · KPR
Merlin Engineering Works, Inc.
Radiology · 638d
Cleared Apr 19, 1995
CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
K941743 · HIG
Cabot Medical Corp.
Obstetrics & Gynecology · 377d
Cleared Apr 19, 1995
TIP DEFLECTOR (GENESIS)
K943257 · DRF
Electro-Catheter Corp.
Cardiovascular · 287d
Cleared Apr 19, 1995
MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE
K945612 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 155d
Cleared Apr 19, 1995
BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY...
K950341 · FLE
Barnard and Assoc.
General Hospital · 82d
Cleared Apr 19, 1995
TECOTHANE 55D
K950425 · GZF
Medtronic Vascular
Neurology · 76d
Cleared Apr 19, 1995
TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
K950532 · EAP
Trophy Radiologie
Radiology · 71d
Cleared Apr 19, 1995
KAPLAN-SIMPSON INFUSASLEEVE CATHETER
K950615 · QEY
Localmed, Inc.
Cardiovascular · 68d
Cleared Apr 19, 1995
MEDI - PUMP
K950867 · CAF
Thomas Industries
Anesthesiology · 51d