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
122353–122376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 1991
I/A HANDPIECE WITH REPLACEABLE TIPS
K910245 · GBX
Surgical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Apr 22, 1991
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION
K910291 · DSI
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Apr 22, 1991
PRESSURE MONITORING EXTENSION LINE
K910378 · DQO
Professional Medical Services
Cardiovascular · 83d
Cleared Apr 22, 1991
RESTING EKG ELECTRODE SERIES
K910494 · DRX
Medtronic Andover Medical, Inc.
Cardiovascular · 76d
Cleared Apr 22, 1991
VALLEY FORGE BIPOLAR PEN OR FORCEPS
K910510 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 76d
Cleared Apr 22, 1991
FORTRESS MODEL 760-V 4 WHEEL POWER WHEELCHAIR
K910749 · ITI
Fortress Litestyle
Physical Medicine · 60d
Cleared Apr 22, 1991
FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER
K910751 · INI
Fortress Litestyle
Physical Medicine · 60d
Cleared Apr 22, 1991
FORTRESS MODEL SPIRIT 4-WHEEL POWER WHEELCHAIR
K910753 · ITI
Fortress Litestyle
Physical Medicine · 60d
Cleared Apr 22, 1991
THE PERCEPTOR(TM) STAND ALONE TRANSDUCER
K910764 · DRS
North American Instrument Corp.
Cardiovascular · 81d
Cleared Apr 22, 1991
TEMPERATURE WELL PROBE, TWP SERIES
K910868 · FLL
Gish Biomedical, Inc.
General Hospital · 52d
Cleared Apr 22, 1991
HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS
K910894 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 49d
Cleared Apr 22, 1991
ANTIMICROBIAL AMPICILLIN
K911185 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 35d
Cleared Apr 22, 1991
ANTIMICROBIAL TOBRAMYCIN
K911304 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 28d
Cleared Apr 22, 1991
ANTIMICROBIAL GENTAMICIN
K911305 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 28d
Cleared Apr 22, 1991
SURGICAL TROCAR
K911462 · DRC
Applied Medical
Cardiovascular · 19d
Cleared Apr 22, 1991
LAPAROSCOPIC CLEANING BRUSH INSTRUMENT
K911481 · FDX
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 18d
Cleared Apr 22, 1991
LAPAROSCOPIC SNARE
K911482 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 18d
Cleared Apr 22, 1991
MODIFICATION TO MODEL 90-1460 LASER ADAPTER
K911523 · GEX
Lifestream Int'L, Inc.
General & Plastic Surgery · 18d
Cleared Apr 22, 1991
ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL.
K911555 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 14d
Cleared Apr 22, 1991
ANTIMICROBIAL SUSCEPT. TEST PANEL TICARC./CLAVUL.
K911556 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 14d
Cleared Apr 22, 1991
ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLIN
K911557 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 14d
Cleared Apr 22, 1991
ANTIMICROBIAL SUSCEPT. TEST PANEL CEFONICID
K911559 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 14d
Cleared Apr 22, 1991
GOWN, OPERATING SURGICAL
K911568 · FYA
Huntsville Rehabilitation Foundation
General Hospital · 13d
Cleared Apr 19, 1991
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K902613 · FRN
C.R. Bard, Inc.
General Hospital · 310d