FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
134593–134616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1988
BATTERY PACKS (OTHER THAN CV)
K881885 · FCP
Dowit Service Co., Inc.
Gastroenterology & Urology · 83d
Cleared Jul 26, 1988
SYRETTE
K881992 · EKJ
Oratec Corp.
Dental · 75d
Cleared Jul 26, 1988
DISPOSEABLE MENSTRUAL PANTY
K882109 · HHD
Glamor Plus Co.
Obstetrics & Gynecology · 69d
Cleared Jul 26, 1988
MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS
K882924 · KQM
M.P. Video, Inc.
General & Plastic Surgery · 13d
Cleared Jul 25, 1988
SONAR-AID(R) ULTRASOUND STANDOFF PAD
K874943 · ITX
Geistlich-Pharma
Radiology · 236d
Cleared Jul 25, 1988
BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS
K880550 · BZM
Medimicro Systems, Inc.
Anesthesiology · 167d
Cleared Jul 25, 1988
CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY
K880775 · LFK
Medsurg Industries, Inc.
Gastroenterology & Urology · 150d
Cleared Jul 25, 1988
ABBOTT TESTPACK CHLAMYDIA
K880783 · LJC
Abbott Laboratories
Microbiology · 150d
Cleared Jul 25, 1988
3M CARPAL TUNNEL
K881703 · HRX
3M Company
Orthopedic · 97d
Cleared Jul 25, 1988
ITE TYPE HEARING AID H.A.F. MODEL ELITE
K881754 · ESD
Brown Hearing Aid Centers
Ear, Nose, Throat · 91d
Cleared Jul 25, 1988
ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE
K881787 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Jul 25, 1988
PROFICIENT(TM) PROPHYLAXIS ANGLE
K881974 · EFB
Block Drug Company, Inc.
Dental · 75d
Cleared Jul 25, 1988
CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP
K881985 · EFB
Denticator
Dental · 74d
Cleared Jul 25, 1988
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
K882490 · GIF
R&D Systems, Inc.
Hematology · 39d
Cleared Jul 25, 1988
E-Z-EM(R) LUFKIN BIOPSY NEEDLES
K882601 · GDM
E-Z-Em, Inc.
General & Plastic Surgery · 31d
Cleared Jul 25, 1988
EURO-MED ENDO-CURETTE
K882606 · PCF
Buckman Co., Inc.
Obstetrics & Gynecology · 31d
Cleared Jul 25, 1988
ENDO C BRUSH
K882628 · HHT
Milex Products, Inc.
Obstetrics & Gynecology · 28d
Cleared Jul 25, 1988
GENERAL SURGICAL TABLE AND ACCESSORIES
K882660 · FQO
American Sterilizer Co.
General & Plastic Surgery · 27d
Cleared Jul 22, 1988
CHANGE TO CATHODE POWDER SPECIFICATION
K881904 · DXY
Telectronics and Cordis Pacing Systems
Cardiovascular · 77d
Cleared Jul 22, 1988
MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE
K882174 · DSA
Medtronic Andover Medical, Inc.
Cardiovascular · 65d
Cleared Jul 22, 1988
CARD GUARD, MODEL CG-2000
K882290 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 51d
Cleared Jul 22, 1988
CR-39 PLASTIC LENSES FOR EYEGLASSES
K882308 · HQG
Automated Lens System
Ophthalmic · 49d
Cleared Jul 22, 1988
MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004
K882429 · KRG
Tpl-Cordis, Inc.
Cardiovascular · 38d
Cleared Jul 22, 1988
ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA
K882680 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 23d