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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
80425–80448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2000
MULITPLE MALE LATX CONDOM
K002571 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 90d
Cleared Nov 16, 2000
MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002,...
K002572 · GWG
Medtronic PS Medical
Neurology · 90d
Cleared Nov 16, 2000
ADVANCED UROSCIENCE INNERSHEATH
K002573 · FBK
Advanced Uroscience, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 16, 2000
ECAT ACCEL PET SCANNER
K002584 · KPS
Cti Pet Systems, Inc.
Radiology · 87d
Cleared Nov 16, 2000
INVAC
K002608 · IYE
Duncan Hynd Associates, Ltd.
Radiology · 87d
Cleared Nov 16, 2000
NEWGEN SYSTEM
K002619 · JEY
Stryker Instruments
Dental · 85d
Cleared Nov 16, 2000
SURESMILE SYSTEM
K002620 · EIA
Orametrix, Inc.
Dental · 85d
Cleared Nov 16, 2000
HRH-63 HEAD ARRAY COIL
K002774 · MOS
Mri Devices Corp.
Radiology · 71d
Cleared Nov 16, 2000
SSW-STERILE SOLUTION WARMER
K002859 · LHC
Kmi Kolster Methods, Inc.
General Hospital · 64d
Cleared Nov 16, 2000
SYNTHES 1.5MM TI BROW LIFT SCREW
K002935 · DZL
Synthes (Usa)
Dental · 56d
Cleared Nov 16, 2000
HERACERAM
K002993 · EIH
J.F. Jelenko & Co., Inc.
Dental · 52d
Cleared Nov 16, 2000
CREATININE PLUS
K003261 · JFY
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Nov 16, 2000
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
K003399 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Nov 16, 2000
ALLEGRO TB, ALLEGRO N
K003434 · KPS
Adac Laboratories
Radiology · 10d
Cleared Nov 15, 2000
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
K001685 · MSE
Baxter Healthcare Corp
Gastroenterology & Urology · 167d
Cleared Nov 15, 2000
35/CD CINECONVERTER
K001841 · LMA
Tagarno A/S
Radiology · 149d
Cleared Nov 15, 2000
INTER-OP DURASUL ACETABULAR INSERTS (4MM)
K002575 · LWJ
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Nov 15, 2000
LITWIN CRUICATE ANCHOR
K002600 · MBI
Instrument Makar, Inc.
Orthopedic · 86d
Cleared Nov 15, 2000
SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010
K002843 · EMA
Sultan Chemists, Inc.
Dental · 64d
Cleared Nov 15, 2000
SOLOBOND PLUS
K003153 · KLE
Voco GmbH
Dental · 36d
Cleared Nov 14, 2000
VBMAX
K000654 · CAH
A-M Systems, Inc.
General Hospital · 260d
Cleared Nov 14, 2000
WELCH ALLYN SPOT CHECK DEVICE
K002530 · DXN
Welch Allyn, Inc.
Cardiovascular · 90d
Cleared Nov 14, 2000
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1
K003308 · FLL
Microlife Corp.
General Hospital · 22d
Cleared Nov 13, 2000
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
K001177 · LYR
Enteric Products, Inc.
Microbiology · 216d